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 is seeking a highly ambitious, adaptable, structured, and detail-oriented Research Nurse to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR), Laboratory of Clinical Immunology and Microbiology (LCIM), Rockville, MD.
- Coordinate with clinical staff to plan, implement, monitor and manage clinical protocols with Internal Review Board (IRB) requirements.
- Collaborate with clinical staff to develop and maintain trial related documents and operational procedures.
- Assist with protocol and consent development and review, including schedule of events, sample collection and laboratory testing, reporting to the IRB, and human subject protection.
- Monitor protocol compliance.
- Oversee the collection, distribution and filing of regulatory documents.
- Prepare all documents for amendment submissions to the IRB including the changes to the protocol and cover memo detailing the changes.
- Work with Investigator to ensure patient safety monitoring is completed in a timely manner.
- Recruit and screen patients for inclusion in protocols/clinical trials.
- Perform patient assessments and collect medical histories.
- Abstract data from patient charts, medical records, questionnaires and diagnostic tests.
- Administer protocol consents and documentation to study participants.
- Direct and perform quality assurance and quality control activities as they relate to protocol adherence and monitoring, data collection, data abstraction, and data analysis and ensure standard operating procedures reflect the highest standards of data integrity and patient safety.
- Manage databases and coordinate data collection.
- Enter patient and sample data in the appropriate databases.
- Coordinate the handling of laboratory and patient samples including appropriate storage, shipping and tracking.
- Follows up with patients to ensure completion of questionnaires, return of samples, etc.
- Maintain all appropriate ethical and regulatory training and qualifications.
- Monitor key ethical and legal issues related to protection of research participants, adherence to policies for the appropriate use of biospecimens and adherence to federal and state regulations surrounding the collection, storage, dissemination and use of biospecimens.
Experience Required / Requirements
- Must have current licensure to practice as a nurse in the state of Maryland.
- Must have malpractice insurance.
- Must have education, training, and experience equivalent to a Registered Nurse/masters level to advise and serve as an authority and consultant to NIAID Investigators.
- Knowledge of the Code of Federal Regulations, International Council of Harmonization, Good Clinical Practice guidelines, Institutional Review Board guidelines, and the NIH standards for Clinical Research Practice is highly desired.
- Knowledge of the research process, the importance of adherence to protocols, and the accuracy needed in collection and documentation of research data.
- Ability to effectively communicate both verbally and in writing, including advanced interpersonal communication skills, presentation skills and professional writing skills.
- Ability to use information technology associated with patient care and research information management.
- 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:
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.