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Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Cell Therapy Manufacturing Laboratory Technician to join our vibrant team at the National Institutes of Health (NIH) supporting the Clinical Center (CC) located in Bethesda, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives
The purpose of this position is to support the clinical manufacturing of hematopoietic stem cells for transplantation, cell and gene therapies that are used for the treatment of patients at the National Institutes of Health Clinical Center. This position involves working in clean rooms per Good Manufacturing Practice regulations. Staff should have experience with aseptic techniques, working in a biosafety cabinet and cell culture.
Deliverables:
- Meet with lab members to present updates - Daily
- Complete documentation per Good Documentation Practices - Daily
- Adhere to NIH Clinical Center and Center for Cellular Engineering policies and procedures - Daily
- Manufacture cell therapy products using aseptic techniques - Daily
- Inspect, clean and operate equipment per standard operating procedures - Daily
Work Details:
- Follow established procedures and protocols; utilize aseptic technique to perform experiments. 1
- Perform routine experiments and tests; follow established procedures and protocols. 2
- Work with a variety of routine and specialized laboratory instruments and equipment in the laboratory. 3
- Collect and enter research data into laboratory notebooks and databases. 4
- Plans, executes, and arranges laboratory experiments, new techniques and procedures; and performs laboratory techniques relating to scientific research.
- Perform routine experiments and tests, including tissue culture, cell separation, protein, and quantitative and qualitative analysis.
- Operates laboratory machines and instruments; and prepares specimens and equipment for use.
- Prepare materials and equipment for experiments.
- Maintain stocked supplies and records of working reagents, including fixatives, buffers, solvents and staining.
- Ensure that all specimens and equipment necessary for experiments are available and in good order.
- Performs sample management and storage.
- Retrieve, catalog and process samples including but not limited to blood and tumor tissue.
- Perform quality control procedures necessary to ensure the accuracy of each test system, sample processing, storage and inventory of samples.
- Ensure that policies and procedures regarding sample retrieval and use are followed.
- Perform processing, description and analysis of samples.
- Work with staff to implement storage and distribution of biological samples for future scientific research.
- Analyzes, documents and reports on all procedures performed.
- Update and maintain written laboratory record of the work.
- Maintain and update laboratory notebooks and databases; and enter experimental data into spreadsheet and conduct statistical analysis.
- Maintains inventory of laboratory supplies.
- Ensure that supplies and consumables are ready and on hand as necessary for maximum efficiency in the laboratory.
- Cleans and sterilizes instruments, glassware and equipment.
- Ensure that adequate clean inventory is available for immediate usage.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
Bachelor's
Additional Qualifications:
Certifications & Licenses
- Good Laboratory Practice (GLP)
- Good Manufacturing Practice (GMP)
- Biosafety Level 2 (BSL 2)
Field of Study
- Biology
Software
- Outlook
Skills
- Aseptic techniques
- Working in a biosafety cabinet
- Cell culture
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Ethics Program Analyst to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute on Minority Health and Health Disparities (NIMHD) located in Bethesda, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives
Conduct initial technical review of financial disclosure reports from staff and Special Government Employees (SGEs) for conflicts of interest; obtain additional information from filer or Committee Management Office (CMO) for clarification and determination of report status. Crosscheck all financial disclosure reports against previously filed reports, SAO lists, HHS-717-1, HHS 520s, HHS 521s and employee's EMIS file to identify conflicts of interest; forward cleared reports to Ethics Program Specialist/Deputy Ethics Counselor (DEC) for final review and certification. Update employees' EMIS files with data about financial disclosure reports after certification. Create new ethics folders for new employees, transferred employees and SGEs
Deliverables:
- Work products and documents related to conducting initial technical review of documents; obtain additional information from filer; crosscheck documents to identify conflicts of interest; forward cleared reports to staff for final review and certification. - Daily
- Work products and documents related to creating new ethics folders; create NIMHD ethics reports; email reminders to OGE 278T filers; conduct initial review of ODAs for completeness of required information; follow up with employee to obtain missing information. - Daily
- Work products and documents related to submitting completed package to Ethics Program Specialist and DEC for review and approval; upload all approved ODAs into EMIS; prepare draft for Ethics Program Specialist and DEC review of ODA requests; upload into EMIS and send final package to NEO Action Coordinator - Weekly
- Work products and documents related to the development of WAGs and issues related to gifts, awards, honorary degrees, Hatch Act violations, and other Federal ethics law matters for Top 5 and other staff. - Ad-Hoc
- Work products and documents related to response to ethics-related data calls. Work products and documents related to conducting initial review of HHS 520s; run report of employees who must file HHS 521s; submit report to Ethics Program Specialist and DEC. Work products and documents related to research of ethics topics; provide documentation for specific regulations. Work products and documents related to materials for presentation at All Staff Meeting. Work products and documents related to ethics clearance for the Advisory Council and SGEs. - Ad-Hoc
- Perform customer service to NIMHD staff. - Daily
Work Details:
- Use various tracking systems, e g, EMIS and NEES to routinely track ethics actions and to provide reports 1
- Gather and analyze information about processes and programs; prepare reports, letters, and other documents for review and input for programs, policies, and activities 2
- Maintain current knowledge of ethics statutes, regulations, legal decisions, policies and procedures and their relationship to the functions of the Office 3
- Use various tracking systems, e g, EMIS and NEES to routinely track ethics actions and to provide reports 4
- Assist with the Coordination the preparation of a variety of items such as travel requests, professional service orders, requests for sponsored travel Form 348, outside activities Form 520, official duty memoranda, training requests, individual and mass mailings, correspondence, reports and various forms 5
- Provides technical experience needed to assist with developing and maintaining a system to analyze and monitor the organization's adherence to the standards of ethical conduct, policies and laws.
- Work with staff to prepare for program audit of ethics policies, procedures and implementation of the relevant regulations; update electronic and paper files; complete pre-audit questionnaires in preparation for entrance conference
- Manage Office documents, adhering to NIH policies for record retention and purging
- Answer inquiries and questions pertinent to submissions as well as general information regarding these matters
- Develop and update presentation and training materials
- Conduct analyses and prepare reports on ethics considerations; recommend policy or procedural changes as appropriate
- Compose standard email notices and responses
- Communicate with employees to explain Ethics information to employees and respond to Ethics questions and issues
- Prepares, manages and tracks flow of various documents submitted for ethics review.
- Manage internal process on incoming Sponsored Travel Official Duty Activities, Protocols and form HHS-717,
- Confidential Report of Financial Interests in Substantially Affected Organizations for Employees of the NIH:
- Work with staff to review other ethics actions to include, but not limited to, financial disclosures, Outside Activity
- Requests, through the NIH Enterprise Ethics System NEES
- Adhere to internal process for receipt and proper routing of forms
- Handle electronic and paper filing of all forms and documents
- Assist in maintaining office records in both paper and electronic form
- Assists with analyzing, maintaining and updating ethnics database, website and filing system.
- Assist with maintaining the Ethics Management Information System EMIS
- Work with staff to develop and maintain a system to analyze and monitor adherence to the Standards of Ethical
- Conduct for Federal employees as well as Ethics policies, laws and regulations for NIH
- Assist with setting up and format spreadsheets to analyze information
- Generate various reports.
- Utilize Ethics Office databases and resources to develop and run reports to identify potential risks and to develop mitigation plans
- Generate monthly reports for senior staff using protocol database
- Assist with the production of spreadsheets with information about lay and professional organizations that interact within NIH for OSPPA
- Conducts first level review for all requests for outside and official duty activities.
- Review submitted documents request package for completeness and accuracy
- Review submission for Ethics compliance with governing statutes and regulations
- Review documents for completeness and accuracy of submission
- Conduct initial technical and/or conflict reviews on the ethics documents and requests
- Maintain the Ethics Management Information System EMIS and NIH Enterprise Ethics System NEES for employees
- Conduct first level review and analysis of all requests for outside and official duty activities, and other actions submitted for ethics review and clearance
- Schedules ethics training sessions and other activities for staff.
- Maintain current knowledge of ethics statutes, regulations, legal decisions, policies and procedures and their relationship to the functions of the Office
- Schedule Ethics training sessions for employees
- Attend and participate in meetings and training sessions for Ethics specialists
- Organize research activities and planned meetings or conferences of the same organizations; update and maintain a constituent list for use by Office of the Director, OSPPA staff and other NIH offices
- Manage orientation training for Ethics-related matters for new Program Support Staff, including initial contact email with links to important Ethics-related information, quarterly Lunch and Learn with Ethics presentations, and ongoing communications and updates as needed for changes to guidance policies and/or procedures
- Provides technical expertise needed to develop and maintain a system to analyze and monitor the organization's adherence to the standards of ethical conduct, policies and laws.
- Work with staff to prepare for program audit of ethics policies, procedures and implementation of the relevant regulations; update electronic and paper files; complete pre-audit questionnaires in preparation for entrance conference
- Manage Office documents, adhering to NIH policies for record retention and purging
- Answer inquiries and questions pertinent to submissions as well as general information regarding these matters
- Develop and update presentation and training materials
- Conduct analyses and prepare reports on ethics considerations; recommend policy or procedural changes as appropriate
- Compose standard email notices and responses
- Communicate with employees to explain Ethics information to employees and respond to Ethics questions and issues
- Analyzes, maintains and updates ethnics database, website and filing system.
- Develop, implement and maintain accessible administrative filing systems
- Manage protocol database and generate weekly reports for senior staff
- Maintain accurate records of phone and e-mail communications with employees and office staff in resolving issues and problems
- Work with staff to organize and maintain shared drive to maintain resources, SOPs, templates and final documentation
- Work with staff to update and develop materials and resources for the Office intranet website
- Maintain the internal Ethics Branch tracking system
- Provides assistance with the review of conflict of interest statements.
- Works in collaboration with the Ethics Program Specialist and DEC
- Answer inquiries and questions pertinent to submissions as well as general information regarding these matters
- Identify potential conflicts of interest; determine resolution of conflicts of interest
- Analyze background information; communicate with staff and/or employee to obtain background information
- Work with staff to research situations regarding conflict of interest situations concerning research and collaborative endeavors with private industry, conflicts concerning prior employment ties to academic institutions and private entities, and the disposal of financial holdings
- Work with staff to provide technical and conflict of interest review on a variety of ethics actions including financial disclosure reports, requests for personal outside activities and official duty activities with outside organizations, board service, recusals, authorizations, and gifts
- Assists with developing the ethics Standard Operating Procedures (SOP) manual.
- Draft standard operating procedures
- Assist with the generation of work products and documents related to creating and maintaining an internal system to analyze and monitor adherence to the Standards of Ethical Conduct for Federal employees as well as Ethics policies, laws and regulations
- Conducts first level review and analysis for all requests for outside and official duty activities.
- Review submitted documents request package for completeness and accuracy
- Review submission for Ethics compliance with governing statutes and regulations
- Review documents for completeness and accuracy of submission
- Conduct initial technical and/or conflict reviews on the ethics documents and requests
- Maintain the Ethics Management Information System EMIS and NIH Enterprise Ethics System NEES for employees
- Conduct first level review and analysis of all requests for outside and official duty activities, and other actions submitted for ethics review and clearance
- Coordinates and monitors the planning of ethics training activities.
- Maintain current knowledge of ethics statutes, regulations, legal decisions, policies and procedures and their relationship to the functions of the Office
- Schedule Ethics training sessions for employees
- Attend and participate in meetings and training sessions for Ethics specialists
- Manage orientation training for Ethics-related matters for new Program Support Staff, including initial contact email with links to important Ethics-related information, quarterly Lunch and Learn with Ethics presentations, and ongoing communications and updates as needed for changes to guidance policies and/or procedures
- Develops the ethics Standard Operating Procedures (SOP) manual.
- Generate work products and documents related to creating and maintaining an internal system to analyze and monitor adherence to the Standards of Ethical Conduct for Federal employees as well as Ethics policies, laws and regulations
- Provide guidance and assistance in drafting administrative policies and procedures
- Work with staff to translate requirements and directives into standard operating procedures SOPs
- Educates staff on new ethical policies and procedures.
- Communicate with employees regarding explanation of Ethics information to staff; respond to Ethics questions and issues
- Communicate with employees to explain Ethics information to employees and respond to Ethics questions and issues
- Ensure the timely distribution of new or revised guidelines or explanations of ambiguous requirements
- Disseminate information to staff summarizing regulations and information from the Office of Government Ethics or the HHS Office of the General Counsel, Ethics Division
- Work with staff on employee training requirements; notify new FTE hires of ethics orientation training requirement
- Ensure compliance and track for completion
- Work with staff in the tracking and completion of annual ethics training
- Provide guidance to office staff on administrative policies and procedures
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
Associate's
Additional Qualifications:
Certifications & Licenses
- Juris doctorate preferred or Master’s degree in a related discipline
- Expert knowledge of Federal Ethics laws and regulations.
Field of Study
- Public Policy
- Public Administration
- Business Management and Administration
- General Business
- Human Resources and Personnel Management
- Miscellaneous Business Medical Administration
Software
- Fellowship systems
- SharePoint
- EMIS
- NEES
- QVR
- PowerPoint
- Excel
- WebEx
Skills
- Expert knowledge of DHHS and NIH Ethics program policies, guidelines and procedures pertinent to outside activities, official duties, financial disclosures, conflicts of interest review of protocols, sponsored travel, awards, honorary degrees, gifts and WAGs.
- Employment Law, career counseling, conflict resolution, alternative dispute resolution, organizational development, talent analytics, recruiting
- Strong communications skills, both oral and written
- Excellent analytical, organizational and time management skills
- Position classification
- Title 42 appointments
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Job Description
Axle Informatics is seeking a Capture Manager with broad strategic perspective and demonstrated performance developing qualified opportunity pipelines by cultivating relationships and marketing research focused solutions across the Federal Health organizations.
Responsibilities
- Identify and qualify opportunities that strategically align with company goals and objectives
- Develop and refine win strategies and associated action plans on targeted pursuits
- Building relationships with potential clients across HHS and identifying areas to market Axle solutions and capabilities
- Respond to RFIs, sources sought, and RFPs
- Identify partnership needs and cultivate partner relationships in collaboration with growth leadership to include opportunity identification and qualification, shaping, selling, and closing capture efforts to win new business.
- Conduct market research and offer strategic recommendations on how advance our business
- Working with the proposal manager and writers to weave together win themes and strategies into our proposal responses and participating in solution development, writing, and reviews
- Drive business to existing GWACs and IDIQs
Required knowledge, skills, and abilities
- Bachelor’s degree in relevant technical field
- 5-8 years of relevant professional experience in the Federal contracting
- Extensive relationships within HHS government stakeholders and firms doing business within
- Ability to influence and interact with government leadership
- Detailed understanding of HHS as well as relationships with key decision makers
- Attention to detail with strong communication, negotiation, client relationship building skills
- Knowledge of various contracting vehicles and the benefits of each
- Ability to understand technical information and communicate it to non-technical stakeholders
- Identify and attend key industry days and conferences
- Excellent computer skills with competence in Word, Excel, and Outlook
- Key personal attributes for success in this role include self-reliance, self-initiative, team building, excellent interpersonal skills, positive demeanor and disposition, and excellent analytical and problem-solving skills
Benefits
- 100% Medical Dental & Vision Coverage for Employees
- Educational Benefits for Career Growth
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Matching
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process, please contact careers@axleinfo.com.
Disclaimer: The above is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job or responsibilities as needed.
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle isseeking a skilled and dynamic Operations Manager to manage and optimizeassignedoperational functions. The successful candidate will play a key role in streamlining workflows, improving data management and reporting, enhancing process efficiency, managing process automation projects and ensuring the overall smooth functioning of assigned corporate functions. The scope of responsibility encompasses a broad spectrum, but will likely include facility and office operations, IT operations, and process analysis and automation, other assigned areas. The ideal candidate should demonstrateexperience in project planning, execution, communication and problem solving. Additionally, the candidate should have demonstrated an aptitude to learnnew technologies and apply them effectively.
Benefits:
- 100% Medical Dental & Vision Coverage for Employees
- Educational Benefits for Career Growth
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Matching
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Responsibilities :
- Supervise Facility and Office Operations to ensure smooth day-to-day functioning.
- Lead and coordinate IT Support Team activities and associated projects.
- Conduct regular assessments of business procedures to identify inefficiencies and enact necessary improvements.
- Cultivate and maintain relationships and agreements with external partners/vendors.
- Utilize data and metrics to evaluate overall performance, providing insightful analysis and interpretation.
- Undertake additional company tasks as required to support organizational goals.
- Foster transparent communication channels between departments to optimize information flow.
- Prepare and deliver comprehensive reports on operational performance to senior management.
- Conduct thorough analysis of existing processes to pinpoint areas for enhancement and efficiency gains.
- Drive the implementation of innovative solutions, automations, and best practices to optimize operational workflows.
- Offer guidance and support to team members, nurturing their professional development.
- Monitor key performance indicators (KPIs) and enact corrective actions as necessary.
- Maintain oversight of quality control measures to ensure consistent delivery of high-quality output.
- Proactively identify potential risks and develop strategies to mitigate and manage them effectively.
Qualifications:
- Bachelors degree in a related field (e.g.,Business Management, Operations Management, Operations Research)
- Experience as an Operations Manager, or equivalent position.
- Excellent writing, communication, and analytical skills.
- Ability to organize, prioritize and multitask.
- Proactive, results-oriented, creative problem solver.
- Strong attention to detail.
- Demonstrated ability to protect sensitive information.
- Knowledge and some experience in operational functions (e.g., finance and accounting, human resources, information technology, data management/reporting etc.)
- Advanced knowledge and experience with the use of MS Word, Excel, PowerPoint, and Project.
- Experience with low code/no code technologies (e.g., MSFT Power Platform
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process, please contact careers@axleinfo.com.
Disclaimer: The above is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job or responsibilities as needed.
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Overview
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Project Manager join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Production Program (VPP).
Responsibilities
- Conduct literature and database research for material needed for scientific programmatic needs.
- Develop and maintain database and website content related to scientific operations under the direction of FTL.
- Document and analyze program activity to identify needs, issues, and development procedural improvements.
- Serve as the subject matter expert (SME) for acquisition justification documentation.
- Under the direction of the Scientific Operations manager, maintain and oversee the VPP supply chain in support of development and production of government vaccine and biotherapeutic investigational products, including, but not limited to:
- Primary VPP contact for government Procurement systems.
- Entry of AMBIS requests.
- Monitoring Procurement request status and troubleshooting as needed.
- Communicating with internal VPP and VRC (as applicable) supply end users to facilitate paperwork required by government procurement systems.
- Remain current with government acquisition regulations (FAR) and communicate relevant changes to VPP Scientific Operations manager.
- Maintain approved supplier list for use by VPP staff.
- Monitors both Commercially Available Goods (CAG), Laboratory Equipment Service Contracts under the FTL, including, but not limited to:
- Ensure stockrooms supply lists remain up to date.
- Gives recommendation to FTL on requests from VPP Scientific Staff for stockroom additions/deletions.
- Periodically review stockroom content with appropriate functional areas to ensure all items are consistent with current VPP processes.
- Coordinate with team leads and Scientific Operations Manager to establish yearly standing order requests to meet programmatic needs with signification needs and lead-times.
- Conduct market research based on technical requirement provided by program staff and makes recommendations to FTL.
- Confirm staff has proper safety training are in place and is followed under the guidance of the Scientific Operations Manager.
- Under the direction of the FTL, liease with VRC management and operations group on VPP facility and operations request via established working group.
- Assist FTL with VPP budgetary operations under direction of FTL:
- Supply expenditures and anticipated project costs per project (monthly basis)
- Analyze program expenditures to provide information to FTL Manager as requested to facilitate periodic budget review (quarterly basis) and project review.
- Develop and maintain database to track program expenses. o Subject Matter Expert for:
- Team members within operations on the subjects of VPP equipment, VPP procurement requests, and receiving.
Experience Required / Requirements
- M.S. degree with minimum of 6 years of federal acquisition experience or bachelor’s degree in federal acquisitions with 8 years of specialized experience in scientific laboratory equipment and consumable acquisitions
- A minimum of 4 years of experience in biopharma/process development environment
- A minimum of 5 years of experience with laboratory operations management
- A minimum of 2 years of experience with ELN/LIMS systems
- Experience in preparation of biological buffers and sterile filtration, preferred.
- Ability to both follow and write/revise SOP’s in the areas of acquisitions and logistics.
- Hands-on experience with inventory management systems
- Expert in Microsoft Office, especially Excel and Word
- Demonstrated programing experience with Smartsheet software.
- Ability to maintain budgetary spending reports.
- Familiarity with general scientific/biotechnology laboratory supply requirements.
- Strong analytical capabilities to prepare inventory analyses.
- Strong communication skills to communicate to internal and external stakeholders.
- Follow established departmental policies, procedures, and objectives, continuous quality.
Benefits
- 100% Medical, Dental & Vision premium coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
careers@axleinfo.com
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Overview
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Biologist join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Immunology Program (VIP)
Responsibilities
- Follow approved SOPs and GCLP guidelines to complete specimen processing of clinical blood samples in an organized, aseptic, high-throughput manner.
- Place and/or remove specimens from appropriate biorepository freezers and liquid nitrogen tanks.
- Accept and sign chain of custody requests for clinical samples sent to and from the NIH Clinic and extramural collaborators following regulatory and protocol requirements.
- Prepare shipments with appropriate labeling and temperature requirements.
- Adjust quickly to changes in schedule as clinical trial volunteers blood draw time or date changes.
- Perform specimen processing using aseptic techniques according to protocol.
- Register and maintain samples in the Laboratory Information Management System (e.g. Freezerworks).
- Wear appropriate Personal Protective Equipment (PPE) in a BSL-2 laboratory.
- Work collaboratively with team members to complete all tasks for the day, but also be accountable as an individual for personal tasks.
- Utilize and maintain various laboratory equipment such as Biological Safety Cabinet (BSC), centrifuge, pipettes, liquid nitrogen tank, and others.
- Write and revise SOPs within VIP’s electronic database.
Experience Required / Requirements
- Bachelors degree in a related field plus 1+ years of experience in a BSL-2 laboratory.
- IT skills such that candidate knows or can quickly learn to utilize LIMS, MasterControl (CQMS), Microsoft Office, etc.
- Ability to work well with others and independently.
- Ideal, but not required: experience in a GCLP environment and IATA infectious substance A and B shipping certification.
- Strong organization and time management skills.
- Detail oriented while performing laboratory tasks.
- Ability to perform under time constraints and meet deadlines.
- Follows directions and protocols without deviations.
Benefits
- 100% Medical, Dental & Vision premium coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
careers@axleinfo.com
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Clinical ResearchCoordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives
The primary role for this Research Coordinator (RC) position is to provide clinical research coordination and protocol navigation for the NINDS Intramural Research Program.
Deliverables:
- Collect participant data; obtain informed consent/assent; respond to and report variances in protocol implement; collect and record research information, perform research procedures as qualified and assigned. - Ad-Hoc
- Manage conflicts/issues in clinical research setting; assess participants and families; provide verbal responses to participants and families; respond to inquiries from the general public and health care professionals regarding clinical research protocols. - Ad-Hoc
- Contribute to interdisciplinary teams, participate in meetings, workgroup processes; provide substantive outcomes; complete assignments within established timeframes. - Daily
- Educate participants and families; perform individualized teaching; advocate and support participants' rights; identify learning needs for practice environment; explore and communicate research issues. - Ad-Hoc
- Work products and documents related to protocol writing and editing; prepare amendments and all necessary forms; develop clinical research and clinical trial protocols, informed consent documents and other regulatory or study-related documents with special attention to the accuracy, consistency, and completeness of documents as well as proper format, spelling, and grammar (in conjunction with the PI and other relevant experts). - Daily
- Work products and documents related to developing clinical documents; review and ensure that protocols and consents meet regulatory requirements and are written in a guideline compatible format. - Ad-Hoc
- Work products and documents related to collaborating with staff on safety, regulatory and monitoring entities; coordinate with staff to integrate and ensure consistency of new/revised documents. - Ad-Hoc
- Work products and documents related to managing, tracking and coordinating regulatory activities for the study protocols, under the guidance of the PIs, from conception/development, through the protocol lifecycle, to study closure. - Ad-Hoc
- Work products and documents related to maintaining all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial; work with staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies. - Ad-Hoc
- Work products and documents related to the organization of regulatory protocol meetings and/or reports; interact closely with the clinical research team and other branch/section staff involved in protocol management; guide the protocol navigation process. - Daily
Work Details:
- Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices. 1
- Prepare and submit for review accurate source documents related to all research procedures. 2
- Prepare and submit Case Report Forms (CRFs) and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields. 3
- Enter data into research databases, systems and applications for ongoing studies. 4
- Assist researchers with study testing, observations data entry and other duties associated with study sessions. 5
- Supports clinical staff develop, implement and maintain clinical research data files and materials.
- Assist preparing and submitting for review accurate source documents related to all research procedures.
- Assists clinical and research staff ensure that Case Report Forms (CRFs) are completed and document changes in
- research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields.
- Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
- Participate in developing and maintaining research protocol documentation and operations.
- Maintains all professional certifications, if applicable.
- Maintain a current clinical trial and clinical research study Good Clinical Practice GCP knowledge base, in order to serve as an expert resource to the client in a regularly changing field, and addresses identified knowledge and skill gaps related to role.
- Attend in-person meetings located at the NIH campus in Bethesda or virtual meetings, including protocol development meetings, research coordinator forum meetings, as well as regular research team meetings.
- Show initiative and strong independent problem-solving skills in making recommendations for improving research team processes in general, and as needed to efficiently resolve complex or unpredictable situations.
- Identify inefficiencies and recommend changes to research protocol documentation procedures that can improve study productivity.
- Independently and effectively troubleshoot issues that arise in clinical research setting, by utilizing strong communication and collaboration skills.
- Maintain a line of communication with the Institutional Review Board IRB to keep abreast of new guidance related to protocol and informed consent submissions for initial reviews and amendments.
- Collects research data and prepares information for inputs and analysis.
- Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.
- Set up, format and enter data into spreadsheets to analyze information and create reports.
- Verify study participants information and collect data and results of testing, including verification data for eligibility criteria.
- Assist researchers in collecting, organizing, and maintaining accurate records of all protocols and study applications, investigator qualifications, study logs, safety reports, annual reports, and correspondence.
- Monitor research team training requirements, including maintaining all training records and providing notifications for training renewal deadlines.
- Supports the development of forms and questionnaires.
- Assist researchers develop, maintain and complete study data collection forms and source documents.
- Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.
- Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries.
- Assist researchers design patient Case Report Forms (CRFs).
- Review draft protocols, case report forms, and manuals of operations (MOPs) for clarity, and completeness, as well as provide input to modify them as needed.
- Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
- Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.
- Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts.
- Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
- Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests.
- Assist researchers with the collection and analysis of research data and samples.
- Adheres to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research including biospecimen handling shipment.
- Complies with processes and procedures required by different types of sponsors and contractual partners eg private industry, federal agency, and investigator.
- Process, maintain and generate reports from research study data and metadata as needed to assist with study monitoring and data sharing requirements, and recommend preemptive actions as needed.
- Monitors subject's progress and reports adverse events.
- Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
- Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.
- Update and maintain logs and records of patient and family contacts.
- Provide continuity of care to patients enrolled on assigned protocols.
- Assesses participants understanding of the information provided during the informed consent process.
- Assesses ongoing consent through discussions with participants and reinforcement of education.
- Identifies and intervenes to address facilitators and barriers to effective informed consent discussions and decision making eg, literacy, capacity, language, distress, lack of time, therapeutic misconception.
- Obtain or confirm informed consent and or assent completion prior to the beginning of any studies or therapies.
- Assist researchers in tracking and reviewing adverse event files in accordance with Institutional Review Board IRB processes and policies.
- Supports assembly, development and review of new research projects.
- Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse
- Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- Assist researchers obtain IRB approval before any study related activities begin.
- Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
- Contributes to discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, data quality, and recommend operational improvements..
- Provides a redacted copy of the informed consent form for regulatory submission at time of continuing review.
- Assist key research personnel in ensuring that clinical research activities are performed in accordance with all federal, state, and NINDS regulations, policies and procedures related to human subjects’ research.
- Assist researchers with developing protocol documentation including schemas, informed consent and assent documents, other regulatory documents.
- Assist researchers in obtaining NINDS approval before any study related activities begin.
- Assist researchers in communicating with IRB, NIH Clinical Center, and other regulatory authorities for protocol approval.
- Supports the creation and management of clinical websites and web-based tools.
- Maintain content on the Clinical Studies websites (resources for staff and extramural investigators).
- Assist researchers register studies on clinicaltrials.gov.
- Work with investigators to Assist researchers submit protocol packages, actions and applications to IRB using the designated protocol tracking and management databases system.
- Organizes and performs clinical research, utilizing internet and other available clinical resources.
- Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms.
- Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.
- Update annual status of recruitment/enrollment in NIH Human Subjects Reporting System.
- Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.
- Schedule and participate in monitoring and auditing activities and coordinate responses to audits.
- Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.
- Assess protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc. and generate quality assurance reports.
- Assist researchers coordinate, facilitate and prepare site for monitoring visits and FDA audits.
- Documents, collects, records, and retains all research related participant encounters including in person, phone, or electronic in the research record eg source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents.
- Maintains the privacy and confidentiality of participant and research data.
- Anticipates and consistently meets reporting deadlines, collaborating with PIs and teams to note data trends and identify problems.
- Participates in developing recruitment materials with input of investigators and IRB approval for referral sources outlining eligibility information.
- Performs and or coordinates outreach activities, as appropriate to meet research recruitment and enrollment goals.
- Notes trends in toxicities, participant information, and data collection points.
- Creates and updates protocol operating policies and procedures eg MOPs as needed.
- Identifies and develops relationships with institutional or community-based resources or groups that can assist in achieving recruitment goals.
- Serves as a communication liaison between interdisciplinary team and the research participant.
- Track and coordinate regulatory activities for all assigned protocols, from conception and development, through the protocol lifecycle, to study closure.
- Protects participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
- Supports clinical staff develop, implement and maintain clinical research data files and materials.
- Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
- Assist researchers with study testing, observations data entry and other duties associated with study sessions.
- Collaborates with principal investigator and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices, as needed.
- Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators,
- NINDS Sponsor representatives, CTU staff, and safety, regulatory, and monitoring entities to ensure all aspects of protocol and regulatory requirements are addressed.
- Support storage and maintenance of all study data and metadata on clinical websites (resources for study team personnel and extramural investigators).
- Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.
- Monitor all aspects of reporting to ClinicalTrials.gov for individual research studies, including keeping track of and providing advance notification to research team of reporting deadlines once study data acquisition has completed.
- Maintain the privacy and confidentiality of participant and research data.
- Protect participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
- Work with investigators to maintain Protocol Applications within the protocol management database system.
- Instruct clinical and research staff in procedures relative to data management.
- Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.
- Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard Operating Procedures and regulatory processes and considerations.
- Organize, prepare and distribute informational materials and provide support to the educational mission of the study.
- Researches changes and updates to Good Clinical Practices (GCP) and prepares summaries, job aids and training materials for research staff and new clinical research coordinators.
- Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations.
- Mentor new clinical research coordinators on all aspects of research support.
- Performs problems-solving and improves processes as needed to resolve complex and or unpredictable situations.
- Manages conflicts issues that arise in clinical research setting, by utilizing strong communication and collaboration skills.
- Mentor new HCPS personnel and serve as an expert resource on all aspects of research support.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
Bachelor's
Additional Qualifications:
Certifications & Licenses
- Association of Clinical Research Professionals Certified Professional (ACRP-CP)
- Association of Clinical Research Professionals (ACRP)
- Certified Clinical Research Professional (CCRP)
- Certified Clinical Research Coordinator (CCRC)
- Certified Clinical Research Associate (CCRA)
Field of Study
- Miscellaneous Health Medical Professions
- Nursing
- Community and Public Health
- General Medical and Health Services
- Neuroscience
- Miscellaneous Biology
- Cognitive Science and Biopsychology
- Biology
- Genetics
- Health and Medical Preparatory Programs
- Nutrition Sciences
- Pharmacy Pharmaceutical Sciences and Administration
- Treatment Therapy Professions
- Communication Disorders Sciences and Services
- Sociology
- Miscellaneous Social Sciences
- Interdisciplinary Social Sciences
- General Social Sciences
- Miscellaneous Psychology
- Clinical Psychology
- Psychology
- Social Psychology
- Social Work
- Chemistry
- Multi-Disciplinary or General Science
Software
- Clinical Trial Management System (CTMS)
- Electronic Medical Records System
- Electronic Data Capture System
Skills
- Overseeing and documenting IP dispensing, inventory and reconciliation
- Closing clinical trial sites down on completion of clinical trial
- Ordering, tracking, and managing IP and trial materials
- Implementation of clinical trial site action plans
- Training clinical trial site staff
- Coordinating project meetings
- Previous clinical trial work
- Electronic medical records
- Protocol review revision
- Phase I or II experience
- Patient confidentiality
- Remote site monitoring
- Regulatory compliance
- Protocol development
- Clinical Research
- Protocol writing
- Clinical Trials
- Data Monitoring
- Data Integrity
- Patient care
- Recruitment
- Scheduling
- Screening
- Research
- ICH/GCP
- SOPs
- Liaising with regulatory authorities
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Linux Administrator and Data Processor to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute on Drug Abuse (NIDA) located in Baltimore, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives
The purpose of this position is to administer several Linux computers in our research facility and to perform basic data processing.
Deliverables:
- Clean Equipment - Ad-Hoc
- Run Validation - Ad-Hoc
- Inspect Equipment - Ad-Hoc
- Meet with lab members to present updates - Ad-Hoc
Work Details:
- Support and maintain scientific computer systems including hardware, operating systems, and associated services in a high-performance computing environment. 1
- Design, develop, document, analyze, create, test and modify computer systems, programs and integrations. 2
- Perform statistical analysis of experimental data obtained at various time points. 3
- Provide performance tuning, hardware upgrades, and resource optimization across the full range of scientific high performance computing architecture. 4
- Utilize knowledge of data structure, data management and various programming language. 5
- Provides technical experience needed to perform analyses, processing and user support of various computer systems using standard statistical procedures and techniques.
- Provide statistical support to staff, including data analysis and the generation tools for researchers to use.
- Provide software recommendations and solutions across diverse scientific applications, including freeware relevant to analyses of scientific discovery.
- Sets up and uses various computer systems and software packages.
- Develop methods for analyzing complex datasets from various sources; document methodological approaches to data analysis performed, including detailed procedures and rationale.
- Compiles and manages data and assists with quality control.
- Drive collection of new data and the refinement of existing data.
- Produces various reports, graphs and figures for presentation.
- Prepare data and analysis for presentations and publication.
- Prepare research data for presentation and manuscripts.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
Bachelor's
Additional Qualifications:
Field of Study
- Computer Administration Management and Security
- Computer and Information Systems
- Computer Programming and Data Processing
- Computer Science
- Chemistry
- Biochemical Sciences
- Physics
Software
- R
- Pandas
- Python
- SQLite
- Linux
- MySQL
- NumPy
- MariaDB
- Bash
- Git
Skills
- Scientific Data analysis
- Statistical modeling
- Database management
- Data visualization
- Linux Administration
- Data cleaning
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking an MRI Technician to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute on Drug Abuse (NIDA) located in Baltimore, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives
This position is a PRN MRI technician at the National Institute on Drug Abuse Intramural Research Program. Work products and documents related to research procedures, including evaluation of new imaging methods and techniques utilizing MRI or TMS; operate Siemens scanner for both human and animal research utilizing both structural and functional MRI.
Deliverables:
- Clean Equipment - Daily
- Run Validation - Daily
- Inspect Equipment - Ad-Hoc
- Work products and documents related to performing quality assurance on scanner, data acquisition and archiving of imaging data; perform different pulse sequence and activation paradigms; focus on reproducibility and quality assurance - Ad-Hoc
- Work products and documents related to acquainting participants with the MRI scanner; perform research related manipulations during MRI experiments. - Ad-Hoc
Work Details:
- Ensure that all research participants, patients and visitors are free of metal objects and other exclusion criteria. 1
- Ensure that everyone entering the scanner room is appropriately screened for MRI contraindications; maintain records of all MRI screening documentation. 2
- Collect and archive MRI data. 3
- Ensure that MR imaging, behavioral and physiological data collected are of the highest quality. 4
- Operate the control console during scanning; select proper imaging sequences; operate peripheral hardware for effective image and data acquisition. 5
- Executes research projects focusing on reproducibility and quality assurance of different pulse sequence and activation paradigms with the assistance of an MRI Physicist.
- Collect Magnetic Resonance Imaging (MRI) brain images, functional MRI images and MR spectra (Magnetic Resonance Spectroscopy).
- Perform clinical and research MRI procedures on patients and animals, including standard clinical MRI scans or more specialized research studies.
- Perform study testing, observations data entry and other duties associated with study sessions.
- Execute research projects focusing on reproducibility and quality assurance of different pulse sequence and activation paradigms with the assistance of an MR physicist.
- Ensure that all human and animal experiments conducted follow applicable NIH standards and regulations.
- Organizes data into computerized data sets.
- Transfer both raw and post-processed images and data to specified databases and/or secure storage media (secure external hard drives and/or DVDs), where they can be stored safely.
- Log all scans performed in the appropriate log book.
- Enter participant/patient data at start of scanning and monitor data acquisition during scanning.
- Create, enter and maintain research data on associated reports and spreadsheets.
- Acts as subject/patient advocate, monitoring comfort and subject cooperation with experimental protocol physiological parameters (pulse rate, respiration, oxygen saturation), and length of time of research exams.
- Adhere to safety precautions and procedures that govern the MRI Facility.
- Ensure the participant’s or patient’s safety and comfort throughout scanning using the patient monitoring system.
- Transfer, position and instruct research participants and/or patients regarding the procedure to obtain the desired radiographic results as specified by the research study.
- Act as a participant advocate for participant safety and comfort.
- Perform all aspects of standard clinical imaging – prepare the patients to be scanned; explain the MRI procedure; acquire consent; address MRI safety screening for contraindications.
- Operates the scanner during both anatomical and functional imaging experiments.
- Operate the MRI scanner doing structural and functional imaging and MR spectroscopy studies, which are part of clinical research studies.
- Perform standard clinical and more specialized research MRI procedures on patients (e.g., functional MRI, diffusion MRI, MR spectroscopy, or animal scans).
- Schedules investigators' time on the scanner.
- Assist in scheduling of research participants for MRI scans to achieve a smooth flow and optimal utilization of the Facility.
- Solves MRI related technical questions by designing and performing independent technical research work.
- Work with research fellows to assist development of new research protocols.
- Trains users on how to operate the scanner and gain independence in their experiments.
- Train research staff and other staff on scanner operation and MR safety issues.
- Provides expert level information on the software and hardware capabilities of the MRI scanner.
- Advise staff on any problems that may need attention.
- Provides input to decide what modifications of the unit are necessary to produce optimum image spectra and most efficient use of the scanner.
- Identify equipment malfunctions and notify appropriate personnel in case of malfunctions; schedule and/or perform routine equipment maintenance functions.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
MRI Technology
Work Schedule
It is expected to be Saturdays and potentially a few hours on one Monday a month.
Certifications & LicensesCompletion of Accredited MRI Technology Program in Medical Imagery or related science field
Field of Study
- Medical Technologies Technicians
- Miscellaneous Health Medical Professions
- Medical Assisting Services
Software
MS Office
SkillsOperating an MRI scanner
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Clinical Research Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives
The primary role for this Research Coordinator (RC) position is to provide clinical research coordination through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific groups as assigned.
Deliverables:
- Collect participant data; obtain informed consent/assent; respond to and report variances in protocol implement; collect and record research information, perform research procedures as qualified and assigned. - Ad-Hoc
- Manage conflicts/issues in clinical research setting; assess participants and families; provide verbal responses to participants and families; respond to inquiries from the general public and health care professionals regarding clinical research protocols. - Ad-Hoc
- Contribute to interdisciplinary teams, participate in meetings, workgroup processes; provide substantive outcomes; complete assignments within established timeframes. - Daily
- Educate participants and families; perform individualized teaching; advocate and support participants' rights; identify learning needs for practice environment; explore and communicate research issues. - Ad-Hoc
Work Details:
- Participate in coordination and management of most daily activities of the study and ensure that study activities follow established protocol, Standard Operating Procedures (SOP), and utilizes approved forms, templates and practices. 1
- Prepare and submit for review accurate source documents related to all research procedures. 2
- Prepare and submit Case Report Forms (CRFs) and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields. 3
- Enter data into research databases, systems and applications for ongoing studies. 4
- Assist researchers with study testing, observations data entry and other duties associated with study sessions. 5
- Supports clinical staff develop, implement and maintain clinical research data files and materials.
- Assist preparing and submitting for review accurate source documents related to all research procedures.
- Assists clinical and research staff ensure that Case Report Forms (CRFs) are completed and document changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and other re-quired fields.
- Maintain and update files of all applicable regulatory documentation for Institutional Review Board (IRB).
- Participate in developing and maintaining research protocol documentation and operations.
- Maintains all professional licenses and certifications, if applicable maintain a current clinical trial and clinical research study Good Clinical Practice GCP knowledge base, in order to serve as an expert resource to the client in a regularly changing field, and addresses identified knowledge and skill gaps related to role.
- Collects research data and prepares information for inputs and analysis.
- Verify study participant information and collect data and results of testing.
- Perform accurate and timely data analysis, report results and findings and respond to sponsor queries.
- Set up, format and enter data into spreadsheets to analyze information and create reports.
- Supports the development of forms and questionnaires.
- Assist researchers develop, maintain and complete study data collection forms and source documents.
- Assist staff writing and editing clinical research protocols and informed consent forms (ICFs) based upon templates.
- Review draft protocols, case report forms, and manuals of operations for clarity, and completeness.
- Work with staff on the design, development and preparation of documents such as spreadsheets, letters, rosters, agendas, presentations and meeting minutes/summaries.
- Assist researchers design patient Case Report Forms (CRFs).
- Supports the collection of data from patient charts, medical records, interviews, questionnaires, and diagnostic tests.
- Retrieve research related information from medical records, hospital information system and laboratory information system and create spreadsheets and other reports for use in study analysis.
- Prepare patient charts for clinic days and provide initial or follow-up assessment forms, patient labels, most recent medication lists and lab and procedure printouts.
- Assist staff screen prospective study subjects and participate in scheduling participants for research visits and procedures.
- Schedule and coordinate outpatient and inpatient visits, diagnostic studies and medical tests.
- Assist researchers with the collection and analysis of research data and samples.
- Adheres to applicable Federal, State, and NINDS regulations, policies, and procedures related to clinical research including biospecimen handling shipment.
- Complies with processes and procedures required by different types of sponsors and contractual partners eg private industry, federal agency, and investigator.
- Monitors subject's progress and reports adverse events.
- Liaison between the study subjects and the investigators concerning any problems or adverse events including out of range vitals, etc.
- Observe data collection and monitoring of withdrawals and assist reporting deviations and adverse events.
- Update and maintain logs and records of patient and family contacts.
- Provide continuity of care to patients enrolled on assigned protocols.
- Assesses participants understanding of the information provided during the informed consent process.
- Assesses ongoing consent through discussions with participants and reinforcement of education.
- Identifies and intervenes to address facilitators and barriers to effective informed consent discussions and decision making eg, literacy, capacity, language, distress, lack of time, therapeutic misconception.
- Obtain or confirm informed consent and or assent completion prior to the beginning of any studies or therapies.
- Supports assembly, development and review of new research projects.
- Assist protocol staff submit initial applications, amendments, continuing reviews, Adverse Events, Serious Adverse
- Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- Assist key research personnel ensure that clinical research activities are performed in accordance with federal, state and institutional regulations, policies and procedures.
- Assist researchers plan and coordinate the initiation of research study protocol and the implementation of operating policies and procedures.
- Contributes to discussions regarding feasibility of protocol implementation and execution with a specific focus on clinical issues, available resources, study coordination, participant safety, and data quality.
- Provides a redacted copy of the informed consent form for regulatory submission at time of continuing review.
- Supports the creation and management of clinical websites and web-based tools.
- Maintain content on the Clinical Studies websites (resources for staff and extramural investigators).
- Collaborate with information technology (IT) staff to perform updates to a variety of websites.
- Create mock ups and visualizations to illustrate to web developers how to execute web enhancements or new web requirements.
- Organizes and performs clinical research, utilizing internet and other available clinical resources.
- Monitor electronic medical record system to ensure necessary components are present and complete such as data collection forms, progress notes, participant information forms and diagnostic test completion forms.
- Coordinate with relevant parties regarding data sharing plan review and tracking of data submission per approved plans.
- Update annual status of recruitment/enrollment in NIH Human Subjects Reporting System.
- Provides assistance to staff in the collection, development and quality control of essential clinical research efforts.
- Schedule and participate in monitoring and auditing activities and coordinate responses to audits.
- Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient appointments and inpatient admissions, travel arrangements, investigation consent, subject longitudinal monitoring, study data, sample collection and data entry.
- Assess protocols and studies for regulatory compliance, adherence to IRB approvals and Federal standards, such as HIPAA, human subject ethics, privacy, etc. and generate quality assurance reports.
- Assist researchers coordinate, facilitate and prepare site for monitoring visits and FDA audits.
- Documents, collects, records, and retains all research related participant encounters including in person, phone, or electronic in the research record eg source documents, case report forms according to regulations, guidelines, and institutional specific policies, including ensuring good documentation practices for all documents.
- Maintains the privacy and confidentiality of participant and research data; Protects participant, protocol, and scientific confidentiality by ensuring security of research data and personal health information.
- Anticipates and consistently meets reporting deadlines, collaborating with PIs and teams to note data trends and identify problems.
- Participates in developing recruitment materials with input of investigators and IRB approval for referral sources outlining eligibility information.
- Performs and or coordinates outreach activities, as appropriate to meet research recruitment and enrollment goals.
- Notes trends in toxicities, participant information, and data collection points.
- Creates and updates protocol operating policies and procedures eg MOPs as needed.
- Identifies and develops relationships with institutional or community-based resources or groups that can assist in achieving recruitment goals.
- Serves as a communication liaison between interdisciplinary team and the research participant.
- Supports clinical staff develop, implement and maintain clinical research data files and materials.
- Assist researchers with study testing, observations data entry and other duties associated with study sessions.
- Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for study drugs, biologics, and devices.
- Develops and facilitates training to new research coordinators and mentors researchers in Good Clinical Practices.
- Instruct data entry and clinical staff in procedures relative to data management, protocol instructions, Standard
- Operating Procedures and regulatory processes and considerations.
- Organize, prepare and distribute informational materials and provide support to the educational mission of the study.
- Researches changes and updates to Good Clinical Practices (GCP) and prepares summaries, job aids and training materials for research staff and new clinical research coordinators.
- Prepare materials, coordinate scheduling, track attendance and report results of workshops related research best practices, emerging trends in clinical studies, new literature and findings and regulatory considerations.
- Mentor new clinical research coordinators on all aspects of research support.
- Performs problems-solving and improves processes as needed to resolve complex and or unpredictable situations.
- Manages conflicts issues that arise in clinical research setting, by utilizing strong communication and collaboration skills.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
Bachelor's
Additional Qualifications:
Certifications & Licenses
- Association of Clinical Research Professionals Certified Professional (ACRP-CP)
- Association of Clinical Research Professionals (ACRP)
- Certified Clinical Research Professional (CCRP)
- Certified Clinical Research Coordinator (CCRC)
- Certified Clinical Research Associate (CCRA)
Field of Study
- Miscellaneous Health Medical Professions
- Nursing
- Community and Public Health
- General Medical and Health Services
- Neuroscience
- Miscellaneous Biology
- Cognitive Science and Biopsychology
- Biology
- Genetics
- Health and Medical Preparatory Programs
- Nutrition Sciences
- Pharmacy Pharmaceutical Sciences and Administration
- Treatment Therapy Professions
- Communication Disorders Sciences and Services
- Sociology
- Miscellaneous Social Sciences
- Interdisciplinary Social Sciences
- General Social Sciences
- Miscellaneous Psychology
- Clinical Psychology
- Psychology
- Social Psychology
- Social Work
- Chemistry
- Multi-Disciplinary or General Science
Software
- Clinical Trial Management System (CTMS)
- Electronic Medical Records System
- Electronic Data Capture System
Skills
- Overseeing and documenting IP dispensing, inventory and reconciliation
- Closing clinical trial sites down on completion of clinical trial
- Ordering, tracking, and managing IP and trial materials
- Implementation of clinical trial site action plans
- Training clinical trial site staff
- Coordinating project meetings
- Previous clinical trial work
- Electronic medical records
- Protocol review revision
- Phase I or II experience
- Patient confidentiality
- Remote site monitoring
- Regulatory compliance
- Protocol development
- Clinical Research
- Protocol writing
- Clinical Trials
- Data Monitoring
- Data Integrity
- Patient care
- Recruitment
- Scheduling
- Screening
- Research
- ICH/GCP
- SOPs
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Overview
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented GCLP Quality Assurance Specialist join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Vaccine Research Center (VRC), Vaccine Immunology Program (VIP)
Responsibilities
- Develop and implement quality control reporting systems.
- Serve as the subject matter expert for GCLP and GLP compliance-related inquiries from both internal and external stakeholders.
- Perform internal inspections to ensure compliance with GCLP standards on a regular (e.g. during testing, monthly, or quarterly basis as required).
- Provide assistance in the SOP management.
- Maintain all master document inventories, program schedules, training files, word documents, and drafts with the Federal Task Leader and relevant GCLP staff.
- Perform or delegate laboratory equipment control documentation and schedule necessary/routine preventative maintenance.
- Review study documentation with management to ensure completeness and ensure proper archival of trial-related materials.
- Maintain archives with proper disposal of documents according to record retention guidelines.
- Prepare appropriate documentation and respond to requests for GCLP inspections and internal/external audits.
- Provide support to management in preparing, tracking, and responding to deviations and CAPA.
- Provide guidance and recommendations for development and improvement of the quality assurance and archival programs.
- Adjust quickly to changes in schedule as priorities shift.
- Wear appropriate Personal Protective Equipment (PPE) when in BSL-2 laboratories.
- Work collaboratively with team members to ensure necessary information is cataloged, digitized, and archived at the end of a study.
- Sustain close and effective communications with VIP management and external collaborators.
Experience Required / Requirements
- BS with 5+ years of experience in a GCLP environment, working with quality assurance.
- IT skills such that candidate knows or can quickly learn to utilize LIMS, CQMS, ELN, Microsoft Office, etc.
- Ability to work well with others and independently.
Benefits
- 100% Medical, Dental & Vision premium coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
careers@axleinfo.com
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Overview
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Scientific Clinical Advisor join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Clinical Research (DCR), Intramural Clinical Management and Operations Branch (ICMOB).
Responsibilities
- Perform history and physical examinations of patients on a research protocol with infectious and allergic disease.
- Serve as a member of the NIAID Ward Team. Working with residents-in-training and fellows to provide care for inpatients.
- Admit patients to the NIAID Inpatient unit to include pediatric and adult patients.
- Participate in clinical practice peer reviews and developing multidisciplinary quality improvement programs and projects.
- Design, implement, and evaluate multidisciplinary quality improvement programs and projects.
- Order and interpret appropriate laboratory and diagnostic studies.
- Provide appropriate patient and family counseling and education with consideration of the patients learning needs, learning readiness and impediments to the process.
- Serve as a liaison providing coordination and communication between NIH institutes and NIAID components through verbal, written and formal presentations to ensure continuity of care.
- Serve as role model for professional practice, collaboration, and communication.
- Lead patient care rounds and conferences.
- Provide backup and support to the Infectious disease consult service nurse practitioner and NIAID Ward team fellow.
Experience Required / Requirements
- Degree from a professional nursing program approved by the legally designated State accrediting agency at the time the program was completed by the applicant is required.
- Active, current registration as a nurse practitioner in a state, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States is required.
- Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects.
- Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
- Minimum 1-3 years of experience as a Family Nurse Practitioner or a combination of experience as an Adult or Pediatric Nurse Practitioner.
- Family Nurse Practitioner Certification (ANCC or AANPCB) or a combination of Adult and Pediatric Nurse Practitioner Certifications.
- Medical malpractice insurance (at the rate of $1M per occurrence and $3M aggregate) and completing the NIH Clinical Center credentialing process are required.
- Credentialing will include and is not limited to peer reference letters, previous employer reference/verification letters with adverse action statements.
Benefits
- 100% Medical, Dental & Vision premium coverage for Employees
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Match
- Tuition reimbursement and professional development opportunities
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact:
careers@axleinfo.com
Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Job Description
The Human Resource Generalist will run the daily functions of the Human Resource (HR) department including administering pay, benefits, and leave, and enforcing company policies and practices.
Duties/Responsibilities:
- Reviews, tracks, and documents compliance with mandatory and non-mandatory training, continuing education, and work assessments. This may include safety training, anti-harassment training, professional licensure, and aptitude exams and certifications.
- Conducts or acquires background checks and employee eligibility verifications.
- Implements new hire orientation and employee recognition programs.
- Performs routine tasks required to administer and execute human resource programs including but not limited to compensation, benefits, and leave; disciplinary matters; disputes and investigations; performance and talent management; productivity, recognition, and morale; occupational health and safety; and training and development.
- Handles employment-related inquiries from applicants, employees, and supervisors, referring complex and/or sensitive matters to the appropriate staff.
- Assist with the payroll cycle utilizing ADP.
- Conduct research on immigration laws and policies to determine the best pathways for immigration needs.
- Attends and participates in employee disciplinary meetings, terminations, and investigations.
- Maintains compliance with federal, state, and local employment laws and regulations, and recommended best practices; reviews policies and practices to maintain compliance.
- Maintains knowledge of trends, best practices, regulatory changes, and new technologies in human resources, talent management, and employment law.
- Performs other duties as assigned.
Required Skills/Abilities:
- Excellent verbal and written communication skills.
- Excellent interpersonal, negotiation, and conflict resolution skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Ability to prioritize tasks and to delegate them when appropriate.
- Ability to act with integrity, professionalism, and confidentiality.
- Thorough knowledge of employment-related laws and regulations.
- Proficient with Microsoft Office Suite or related software.
- Proficiency with or the ability to quickly learn the organizations HRIS and talent management systems.
Education and Experience:
- Bachelor’s degree in Human Resources, Business Administration, or related field required.
- At least 1-3 years of human resource management experience preferred.
Benefits
- 100% Medical Dental & Vision Coverage for Employees
- Educational Benefits for Career Growth
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Matching
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process, please contact careers@axleinfo.com.
Disclaimer: The above is meant to illustrate the general nature of work and level of effort being performed by individual’s assigned to this position or job. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job or responsibilities as needed.
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Clinical Neuropsychologist to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Mental Health (NIMH) located in Rockville, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives
Under this delivery order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health. The primary objective is to provide services and deliverables through performance of support services.
Deliverables:
- Work products, reports, and documents related to clinical and research neuropsychological testing of medically ill and healthy research participants. - Daily
- Work products and documents related to administering neuropsychological, intellectual and psychological assessment instruments (tests) for inclusion in protocol research reports. Summary documents of evaluations carried out for different protocols. - Daily
- Work products and documents related to maintaining electronic records and computerized research databases containing participant information and test results. - Daily
- Work products and documents related to education of patients, families and staff and individualized teaching of trainees. - Daily
Work Details:
- Customized testing may include computerized batteries de-signed to address specific patient abilities, such as reaction time testing, smell testing, or speech measures. The Contractor will utilize knowledge of a broad range of neuro-psychological testing and current literature to advise Government staff on appropriate testing options for achieving the protocol goals. 1
- Assist in collation of research results for publication according to the timeline requested by the Government staff. 2
- Provide expert consultation regarding study design and analysis and use of psychological instruments. 3
- Provides screening and recruitment of patients for research protocols.
- Perform neuropsychological assessment of adults and children under the direction of Government staff. Contractor will be responsible to conduct interviews (of research subjects and family informants) and administer and score tests accurately.
- Coordinates scheduling and evaluations of patients within each protocol.
- Testing shall include standard and customized tests of intelligence and other neuropsychological domains, including but not limited to learning/memory, personality, mood in support of the NIH intramural research program.
- Provides clinical support to patients and their families throughout the time they are participating in research protocols.
- Conduct analysis and interpretation of test results consistent with best practices in the field of neuropsychology.
- Conducts psychological testing of patients and healthy control subjects.
- Prepare and provide written and verbal feedback and reports for the referral source and to research subjects (upon request). Contractor will document reports on the patient’s electronic medical record. Reports shall include deliverables documenting all neuropsychological and psychological tests administered, individual performance on the tests as compared with normative data, interpretation of the data based on best practices in the neuropsychology field, and numerical test data for individual patients.
- Administers and interprets psychological assessments to probands and family members as part of the research protocol.
- Conduct pre and post-operative neuropsychological assessment of patients undergoing various medical procedures.
- Assess the cognitive status of potential candidates for neurosurgical procedures such as deep brain stimulation or ablation.
- Participates in the planning and execution of clinical research.
- Carry out standardized assessments for phenotype classification of participants in re-search studies.
- Educates research staff regarding the use, strengths and limitation of psychological testing.
- Develop new protocol-specific tests related to protocol(s) under study in consultation with Government staff.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
PhD
Additional Qualifications:
Certifications & Licenses
- American Board of Clinical Psychology (ABCP)
Field of Study
- Clinical Psychology
Software
- Computer skills to include MS Office Suite.
Skills
- Clinical trial management, work with special populations (children, adolescents, adult, elderly)
- Family intervention, clinical assessments, recommendations for appropriate referrals
- Cognitive Behavioral Therapy
- Interpersonal therapy (IPT)
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Laboratory Technician to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives
Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Institute of Neurological Disorders and Stroke. The primary objective is to provide services and deliverables through performance of support services.
Deliverables:
- Manage work products and documents related to performing laboratory techniques and procedures, including handling infectious agents, performing immune cell isolations, immunohistochemistry, tissue sectioning, fluorescence and brightfield microscopy. - Daily
- Manage work products and documents related to performing digital flow cytometry, ELISAs, DNA/RNA isolations, PCR, RT-PCR, quantitative PCR and Western blots. - Daily
- Manage work products and documents related to working with staff on the maintenance of transgenic mouse colony, cell lines, logs and databases. - Daily
- Manage work products and documents related to inventory supplies and equipment; prepare purchase requests. - Daily
Work Details:
- Perform a variety of laboratory techniques and procedures, including handling infectious agents, performing immune cell isolations, immunohistochemistry, tissue sectioning, fluorescence and brightfield microscopy. 1
- Perform digital flow cytometry, ELISAs, DNA/RNA isolations, PCR, RT-PCR, quantitative PCR and Western blots. 2
- Work with staff on the maintenance and screening of transgenic mouse colony. 3
- Maintains inventory of laboratory supplies and initiates purchase orders.
- Monitor and inventory routine laboratory supplies; ensure that supplies are stocked and organized.
- Monitor inventory levels and proper storage of materials and supplies in accordance with established policies and procedures.
- Performs advanced equipment maintenance.
- Coordinate general laboratory maintenance, including equipment upkeep and calibration.
- Trains staff in performing routine laboratory tests and procedures.
- Provide technical help and expertise to lab members.
- Train new laboratory members in the correct use of equipment, application of techniques and laboratory protocols.
- Work with staff on the maintenance of laboratory cell lines.
- Work with staff on the maintenance of laboratory logs and databases.
- Inventory laboratory supplies and equipment, make recommendations and prepare purchase requests.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
Bachelor's
Additional Qualifications:
Certifications & Licenses
- Good Laboratory Practice (GLP)
Field of Study
- Biology
Software
- Powerpoint
- Outlook
Skills
- Strong Oral and Written communication.
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a highly ambitious, adaptable, structured, and detail-oriented Senior Clinical Research Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID).
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Axle is seeking a Senior Clinical Research Advisor to join our vibrant program team supporting the National Center for Advancing Translational Sciences (NCATS), Division of Clinical Innovation (DCI), Clinical and Translational Science Awards (CTSA) Program located in Bethesda, MD. The CTSA Program is the single largest research program at the National Institutes of Health (NIH). Through this program, the Division of Clinical Innovation (DCI) within NCATS invests annually to promote new methods and technologies that address bottlenecks and enhance the translational research pipeline to speed the delivery of new drugs, diagnostics and medical devices to patients. Currently, more than 50 medical research institutions across the nation receive CTSA Program funding toward this mission.
The selected individual shall provide the DCI Director with senior-level scientific program support in accomplishing the CTSA goals and objectives.
Responsibilities:
- Perform scientific program management support services virtually and/or onsite at the NIH in coordination with the DCI Director.
- Apply expert knowledge and educational background in clinical research and translational medicine to support and coordinate vital activities executed by the DCI Trial Innovation Network (TIN), including surveillance of 50+ program hub award institutions.
- Collaborate with NCATS and DCI to develop new TIN Funding Opportunity Announcements (FOAs).
- Explore and contrast existing NIH funding mechanisms as potential formats.
- Collaborate with DCI staff to gather data pertinent to the development of new TIN FOA(s).
- Analyze data and identify gaps and opportunities.
- Identify opportunities for synergy and collaboration with external stakeholders.
- Collaborate with the NIH Office of Extramural Research (OER), program, and review staff to obtain necessary information.
- Establish and oversee DCI working groups to review and make recommendations regarding existing and new TIN FOA components.
- Develop presentations and reports; develop metrics for strategic management of the TIN.
- Support the administration of several large awards in the TIN program.
- Contribute expertise and knowledge to DCI in support of its efforts to foster innovation and deliver national leadership in the growing area of clinical and translational science (CTS), which is a distinct research discipline.
- Participate with DCI leadership in expanding its advocacy and sponsorship of initiatives related to excellence in data management and innovative approaches to the management and standardization of translational research data.
- Assist in expanding DCI’s collaboration with other NIH Institutes/Centers (ICs) and the scientists they support, and foster efforts that strengthen communication among stakeholders across the clinical spectrum, including patients, industry, and regulators.
Qualifications:
- Medical degree from an accredited university.
- Board certified and licensed in a medical-related field or D.D.S. in a state, territory or commonwealth of the United States or District of Columbia.
- Ten (10) years of experience in clinical trial research.
- Required prior involvement in clinical trials as an investigator or medical monitor.
- Well-versed in multiple disciplines, including the broad application of information technology; interpretation of information from a wide variety of sources including biological sequences and molecules; potential research uses of electronic health records (EHR); and issues related to clinical studies, clinical trials, and rare diseases.
- Familiar with National Institutes of Health (NIH) and Department of Health and Human Services (HHS) human subjects’ policies; Institutional Review Board (IRB) policies and subject safety; and data sharing and confidentiality issues.
- Familiar with specific NIH grant mechanisms (e.g. UM1, U24, etc.).
- Expertise in clinical trials, basic research, management of large networks, and have regulatory experience.
- Expert knowledge of clinical research and care in academic and/or community clinical settings.
- Educational background and training in clinical medicine are paramount.
- Experience in establishing and promoting a vision of innovation in the growing area of clinical and translational science is critical.
- Demonstrated track record of applying translational science concepts to deliver innovative solutions to clinical research problems while working collaboratively and utilizing a consultative approach to problem solving and decision.
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Data Analyst to join our vibrant team at the National Institutes of Health (NIH) supporting the National Center for Advancing Translational Sciences (NCATS) located in Rockville, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Axle is seeking a Data Analyst with experience in SQL, R and Python to join our vibrant team at the National Institutes of Health (NIH) supporting the National Center for Advancing Translational Sciences (NCATS). The position is within the Compound Management (CoMa) group at NCATS.
Responsibilities –
CoMa supports many NCATS scientists and their collaborators in their research by supplying and storing libraries of chemical compounds and small molecules for high throughput screening and research.
Primary responsibilities of the role are as follows –
- Utilize SQL, Python, or Java to extract, manipulate, and analyze data sets to derive meaningful insights.
- Proficiently manage lab data, including data entry, tracking, and retrieval systems. Collaborate with lab personnel to streamline data collection processes and ensure accurate documentation.
- Implement quality control measures to ensure data accuracy and consistency. Identify and resolve data discrepancies and anomalies in a timely manner.
- Work with other application development team members to coordinate the creation, management, and improvement of existing and new workflows. Write complex SQL queries, joins, tables will be a requirement for this position.
- Work with other application development teams to coordinate the creation, management, and improvement of new and existing web applications.
- Develop and manage data analytics and visualizations for NCATS researchers using Palantir Foundry software.
- Stay abreast of emerging trends, tools, and technologies in data analysis and laboratory informatics. Proactively seek opportunities for professional development and skill enhancement
Qualifications -
- The pace of work at NCATS requires individuals to have an excellent work ethic and ability to work independently and with a group.
- Have obtained a Bachelor's or master’s in Bioinformatics, Computer Science, Statistics, Data Science, Engineering, or related STEM field.
- Able to work 40hrs/week.
- Ability to work independently, just as well as with general supervision.
- The ability to work in a fast-paced environment with changing priorities.
- Skilled in a scripting language (Python, R, SQL needed; Java preferred)
- Skilled/Experienced in data extraction and handling.
- Excellent oral and written communication skills.
- A good understanding of mathematical and statistical concepts and a passion for learning data analytics is a must.
- A willingness to learn and adapt is a must.
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).
Axle is seeking a Scientific Program Analyst to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Mental Health (NIMH) located in Bethesda, MD.
Benefits We Offer:
- 100% Medical, Dental & Vision Coverage for Employees
- Paid Time Off and Paid Holidays
- 401K match up to 5%
- Educational Benefits for Career Growth
- Employee Referral Bonus
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
Overall Position Summary and Objectives
Under this task order, the contractor will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health (NIMH). The primary objective is to provide services and deliverables through performance of support services.
Deliverables:
- Work products and documents related to retrieving data related to the review and administration of extramural grants from NIH and NIMH grants databases; participating in meetings; gathering and preparing relevant materials for distribution. - Ad-Hoc
- Work products and documents related to planning and carrying out special studies and analyses of DSIR research portfolios; developing responses to requests for information. - Ad-Hoc
- Work products and documents related to conducting library and computer searches of scientific literature; locating and gathering published papers on specific topics; preparing summaries. - Ad-Hoc
- Work products and documents related to supporting NIMH initiative development processes, workshops and meetings; contributing written summaries of analysis for inclusion in reports and presentations. - Ad-Hoc
- Work products and documents related to assisting Program staff with the review of grant applications and progress reports; including information related to human subjects monitoring, participant consent documents, recruitment and milestone monitoring, and data sharing agreements. - Ad-Hoc
- Work products and documents related to maintaining current knowledge of ethical conduct requirements, conflict of interest policy, computer security, working knowledge of relevant eRA modules, data and portfolio analysis tools and systems, and applications as necessary. - Ad-Hoc
Work Details:
- Work with staff on existing projects and/or the development, initiation and execution of new project initiatives. 1
- Conduct literature searches in PubMed, Web of Science and other information sources; manage references using bibliographic software. 2
- Prepare scientific and programmatic presentation materials such as tables, graphs, slides, abstracts, posters and overheads by assimilating and mastering the scientific data and programmatic con-text for use at presentations and meetings. 3
- Attend meetings, training and conferences in support of program initiatives. 4
- Work with staff to coordinate and plan scientific meetings, including communications with distinguished lecturers, invited guests and participants, registration and meeting logistics. 5
- Researches and evaluates the operation of the organization's scientific programs.
- Work with staff on the concept development, planning, execution and support of all project-related activities.
- Organize and maintain project documentation and communications; track project progress using project management tools.
- Track action items and tasks, provide deadline reminders to Program staff; maintain spreadsheets of relevant information.
- Review and proofread programmatic documents describing scientific and administrative procedures and policies related to program operations.
- Request information from and provide responses to principal investigators program staff and others on scientific and operational/programmatic issues.
- Work with staff on gathering information and reviewing documentation, plans, and reports related to human subjects protection, data safety monitoring, Recruitment Monitoring RMR, and data sharing agreements
- Work with staff on special assignments such as the development of responses to various requests for information, utilizing a range of data and portfolio analysis tools and systems, including Query View Report System QVR, Electronic
- Research Administration eRA Commons system, iSEARCH, RePORTER, and ClinicalTrials.gov websites
- Researches, interprets and summarizes background materials from a variety of scientific sources.
- Conduct search for material for a specific programmatic need, using a database to search for material in many cases.
- Organize and analyze reports in a scientific area as assigned.
- Create scientific search criteria for locating scientific, program and related information on the internet and other means, including literature and NIMH/NIH database searches.
- Conduct library and computer searches of scientific literature related to treatment and preventive interventions for mental disorders, mental health and related topics; locate and gather published papers on specific topics; prepare summaries
- Compiles data and creates and prepares graphs, slides and presentations.
- Analyze and develop presentations consisting of data from progress reports to be used by Program staff and at meetings in the overall analysis of Program progress.
- Conduct searches for material for a specific programmatic need and/or presentation; use a database to search for material as necessary.
- Organize existing slides/presentations/talking points into a functional database/library.
- Design, develop and maintain databases, Listservs, spreadsheets, PowerPoint presentations and other computer applications.
- Collect, read, interpret, analyze and condense material from a variety of sources and prepare reports of data analysis for presentation.
- Prepare presentation materials such as handouts, meeting materials, slide presentations, and background/supplemental documents, spreadsheets, charts and graphs for conferences, committee, .meetings, workshops and group updates.
- Read, interpret, analyze and condense material from a variety of sources for presentation.
- Retrieve data related to the review and administration of extramural grants from NIH and NIMH grants databases
- Performs logistical planning of various scientific meetings, lectures, workshops.
- Develop a template for reporting meeting minutes to Program staff.
- Perform logistical planning for various scientific meetings, conference calls, symposia, lectures, workshops and special projects.
- Work with staff to identify key issues and track action items and tasks, providing deadline reminders to Program staff and update and maintain spreadsheets of relevant information.
- Represent the Program at local and national meetings; deliver presentations and posters; disseminate details of the
- Program and collect information of value to the Program goals.
- Identify, draft, edit, revise and assemble necessary background materials for meetings, workshops, and conferences; draft, review and proofread programmatic documents, such as agendas, letters to participants/presenters, participant lists, handouts, emails, thank you letters and reports.
- Support NIMH initiative development processes, workshops and meetings with program staff and NIMH leadership in pursuit of division priorities and the NIMH Strategic Plan
- Participate in related meetings, including the DSIR Division meeting, NIMH All Hands Meetings, NIMH Council
- Meetings and assist in gathering and preparing relevant materials for distribution
- Demonstrate and expand knowledge of scientific areas through official duties and activities eg, participating in scientific meetings, committees, or consortia; preparing summaries of meetings; preparing reports
- Plans, organizes and participates at a senior level in technical meetings and consultations.
- Prepare and give formal presentations for division leadership and other interest groups.
- Coordinate with strategic project leaders on the logistics annual in-person Committee meetings, monthly teleconferences or videoconferences, and additional teleconferences, videoconferences or electronic reviews to address key issues.
- Maintain ongoing, proactive communication with key personnel throughout the initiative; gather, provide and exchange information with Network investigators, their staff and other relevant individuals.
- Develop and improve procedures for leadership and program staff to implement within-division and cross-division tracking and reporting to gage progress, identify gaps in the portfolio, and assemble data on areas of scientific interest
- Reviews and evaluates the performance of the organization.
- Organize and coordinate program activities; manage agendas, meetings, background materials and minutes.
- Ensure that all aspects of the programs are tracked and reported, key milestones and deliverables dates are known and adhered to, and that all individuals and partners involved are kept appraised of progress of integrated tasks and next steps.
- Draft funding plans; develop milestones and budgets for current and potential projects; and for transitioning projects through different phases and stages.
- Work with the Division leadership and staff on the development of strategic plans, initiatives, solicitations and consultation activities.
- Analyzes existing scientific programs and makes recommendations for improvement.
- Assist Program staff in optimizing standard operating procedures for reviewing research applications and grants to ensure compliance with funding policies and to monitor post-award compliance.
- Assist Program Staff with developing and monitoring a plan to improve the outreach, education, and interaction strategies of the Branch.
- Coordinate Division/Branch efforts to update and maintain the Division Webpages.
- Work with staff to assist and conduct management and administrative analysis; evaluate DSIR procedures, policies, processes and systems for the purpose of improving efficiency.
- Maintain current knowledge of ethical conduct requirements, conflict of interest policy, computer security, working knowledge of relevant electronic research administration eRA modules, databases, and applications
- Develops and prepares various scientific reports.
- Organize and maintain a repository of resources, including minutes, reports, spreadsheets and web pages related to the program.
- Organize, analyze, and write progress updates; contribute to scientific papers, reports, and scientific presentations, based on results and findings.
- Conduct searches using relevant data bases; review and summarize materials and data; gather and coordinate information for review; develop and maintain a system for file maintenance; edit and/or prepare text, data and charts.
- Prepare spreadsheets summarizing research efforts by grant mechanism and/or scientific topic; track project progress and provide regular reports.
- Develops and implements new scientific programs in order to fulfill organizational goals and objectives.
- Maintain and distribute scientific papers relevant to specific programmatic needs.
- Lead efforts to expand the use of social media; develop and implement a plan to use social media channels to keep stakeholders and the research community informed and up to date.
- Track action items and tasks; provide deadline reminders to staff; maintain spreadsheets of relevant information for grants, contracts and other programs.
- Assess alignment of policymakers’ interests with the mission, and work with staff to develop strategies/opportunities to educate/inform policymakers on relevant scientific, education, and outreach efforts,
- Provide project planning and project management strategies to efficiently approach complex tasks.
- Develop and improve procedures for leadership and program staff to implement tracking and reporting to gage progress, identify gaps in the portfolio, and assemble data on areas of scientific interest.
- Collect information on programs and grants to facilitate identification of scientific overlap and/or duplication, future scientific directions, workload distribution, etc.
- Troubleshoot and resolve operational problems related to clinical research protocols.
- Collaborate with staff to plan and carry out special studies and analyses of the research portfolios.
- Work with the Office of Communications and Public Liaison to achieve communications goals regarding dissemination of results of NIMH-supported research and new funding initiatives.
- Develops and maintains clinical database.
- Develop and maintain database and website content related to scientific programs.
- Track clinical research studies for appropriate documentation.
- Develop, update, and maintain information databases (e.g. SharePoint sites); provide document retrieval support.
- Establish and maintain data analytics tools for analysis.
- Work with staff to plan and carry out special studies and analyses of the Division of Translational Research DTR research portfolios
- Work with staff on special assignments such as the development of responses to various requests for information, utilizing a range of data and portfolio analysis tools and systems, including Query View Report System QVR, Electronic
- Research Administration eRA Commons system, iSEARCH, RePORTER, and Clinical Trials gov websites
- Conduct library and computer searches of scientific literature related to treatment and preventive interventions for mental disorders, mental health and related topics; locate and gather published papers on specific topics; prepare summaries
- Retrieve data related to the review and administration of extramural grants from NIH andNIMH grants databases
- Support NIMH initiative development processes, workshops and meetings with program staff and NIMH leadership in pursuit of division priorities and the NIMH Strategic Plan
- Contribute written summaries of analysis for inclusion in reports and presentations to NIH and external audiences
- Develop and improve procedures for leadership and program staff to implement within-division and cross-division tracking and reporting to gage progress, identify gaps in the portfolio, and assemble data on areas of scientific interest
- Communicate with internal and external stakeholders, researchers and applicants
- Work with staff on the coordination of the DTR portfolio, including human subjectsresearch
- Work with staff on gathering information and reviewing documentation, plans, and reports related to human subjects protection, data safety monitoring, Recruitment Monitoring RMR, and data sharing agreements
- Participate in related meetings DTR Division meeting, NIMH All Hands Meetings, NIMH Council Meetings and assist in gathering and preparing relevant materials for distribution
- Demonstrate and expand knowledge of scientific areas through official duties and activities eg, participating in
- scientific meetings, committees, or consortia; preparingsummaries of meetings; preparing reports
- Maintain current knowledge of ethical conduct requirements, conflict of interest policy, computer security, working
- knowledge of relevant electronic research administration eRA modules, databases, and applications
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Minimum Education
Master's
Additional Qualifications:
Certifications & Licenses
- MPH, MS, MSW or other related discipline. Three (3) years of specialized experience in clinical trail research. Two (2) years of specialized experience plus a Bachelor's degree is equivalent to a MPH, MS or MSW.
Field of Study
- Community and Public Health
Software
- MS Office
Skills
- Excellent interpersonal, analytical, organizational and time management skills.
Disclaimer:The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.
Accessibility: If you need an accommodation as part of the employment process please contact: careers@axleinfo.com
Job description:
We are currently hiring an experienced Laboratory Technical Engineer with work experience in electro-optical pneumatic systems. The support includes testing and calibration of Mechanical, Pneumatic, Electro-optic and Software modules. You would be hands on and have a part in servicing an innovative platform that aims to accelerate discovery of new products for vaccine and early clinical product testing including immunoassays and molecular tests for Covid-19 and influenza to name a few.
Responsibilities:
- Conduct daily tests and measurements to validate the performance of the systems as per the system operator
- Perform planned maintenance activities including loading of system consumables and disposition of used consumables.
- Identify and resolve technical issues, working closely with cross- functional teams to implement solutions and optimize system
Qualifications:
- 7 to 10 years of experience with service and integration of medical devices is required.
- 5 years of experience with servicing/integrating complex electro- optic/pneumatic systems is required.
- Formal technical education preferably in mechanical engineering, Electrical/ Optical Engineering, or related field.
- Experience with precision machining and testing of mechanical devices
- Understanding of optics, pneumatic and mechanical aspects of the field
- Experience in working with companies in the bio-medical field.
- Experience working with a team and ability to work independently.
- Excellent problem-solving and communication skills with strong attention to
Location: Gaithersburg, MD and will relocate.
Working Conditions: The role involves working in a laboratory environment with exposure to delicate optical components and precision equipment.
Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries.
Axle is looking for an experienced Technical Account Manager to manage high visibility science and technology projects and client relationships on our federal contracts. The ideal candidate will be a self-motivated, results driven individual with strong technical and presentation skills and executive presence.
Responsibilities:
- Work with technical, account and growth teams to identify new opportunities for growth.
- Provide technical leadership for in-flight projects and programs.
- Work with the Account personnel (technical, delivery or corporate) to identify blockers and and risks.
- Work with build staeholders to mitigate risks/blockers to improve adoption.
- Manage communications and relationships across corporate and client teams and ensure transaprency in communications and delivery.
- Analyze and Implement effective problem resolution methods by utilizing technical and corporate resources.
- Provide prompt technical proposal response
- Have a growth mindset - Increase footprint and cross-sell corporate account and technical capabiltiites.
- Work with technical and service delivery teams to develop and maintain a support plan.
- Communicate proactively with stakeholders regarding product and program information, supportability issues, and strategic product plans.
- Maintain effective working relationships with assigned commercial customers.
- Drive growth in services.
- Maintain and expand working knowledge of current and emerging cloud technologies and products as well as their integration and methods of support delivery.
- Share best practices with team members to contribute to enhance the quality and efficiency of customer support.
- Participate in individual or team projects to enhance the quality and efficiency of software development, support and service delivery
- Establish effective working relationships with Product Groups by working through appropriate escalation channels.
Qualifications
- Master’s degree, Bachelor’s degree or equivalent work experience.
- Experience supporting native cloud applications - development, deployment and support
- Experience with Microsoft Azure, App Registration in Azure.
- Experience with Rest APIs, OAuth 2.0.
- Experience with DevOps, GIT.
- Experience with developing and supporting .NET, JavaScript, JSON, Python code.
- PMP certification - Highly desired
- Federal Healthcare Aplication Development / Support / Service Delivery / Account Management - a big plus
Benefits
- 100% Medical Dental & Vision Coverage for Employees
- Educational Benefits for Career Growth
- Paid Time Off (Including Holidays)
- Employee Referral Bonus
- 401K Matching
- Flexible Spending Accounts:
- Healthcare (FSA)
- Parking Reimbursement Account (PRK)
- Dependent Care Assistant Program (DCAP)
- Transportation Reimbursement Account (TRN)
The diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.