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 Protocol Coordinator 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
The position will independently provide support services to satisfy the overall operational objectives of the National Institute of Mental Health.
- Work products and documents related to administering structured clinical interviews, neuropsychological tests and mood and anxiety rating scales for patients and healthy controls. - Ad-Hoc
- Work products and documents related to assessing the psychosocial needs of patients; documenting initial social work assessment, ongoing progress, disposition and planned aftercare; coordinating scheduling, travel and lodging of subjects participating in studies. - Ad-Hoc
- Work products and documents related to ensuring recruitment of subjects in protocols; identifying and engaging potential referral sources; implementing recruitment procedures. - Ad-Hoc
- Work products and documents related to coordinating, monitoring and updating research protocols; entering data into database; preparing annual reports of protocols for IRB and similar entities. - Ad-Hoc
- Work products and documents related to maintaining laboratory supplies and equipment; identifying hazardous conditions; implementing and maintaining standard safety procedures; training incoming post-bac IRTAs. - Ad-Hoc
- Work products and documents related to submitting protocols to the IRB; monitoring protocol compliance; developing and implementing policies and procedures related to SNFA research; implementing and monitoring all GCP and NIH policies and procedures. - Ad-Hoc
- Work products and documents related to assisting staff with training OP4 nursing staff and others; maintaining database in the use of CTDB and the developing new databases in the REDCap; recruiting research participants by speaking to community groups to increase program visibility. - Ad-Hoc
- Administer structured clinical interviews for DSM-IV Axis I diagnoses (SCID) for both patients and healthy controls. 1
- Administer neuropsychological tests (e.g., IQ, WASI). 2
- Administer mood and anxiety rating scales for patients. 3
- Assess the psychosocial needs of inpatient and outpatient subjects participating in research under observation of medical investigators.
- Document in medical record the initial social work assessment, ongoing progress, disposition and planned aftercare.
- Coordinate scheduling, travel and lodging of subjects participating in studies.
- Ensure recruitment of subjects in protocols.
- Identify and engage potential referral sources.
- Implement and monitor subjects’ recruitment procedures.
- Coordinate and monitor research protocols; update protocols with amendments.
- Ensure that research data are entered into database.
- Prepare annual reports of protocols for IRB and similar entities.
- Maintain laboratory inventory of supplies and equipment.
- Maintain laboratory and equipment in good functioning order.
- Identify hazardous conditions; implement standard safety procedures.
- Train incoming post-bac IRTAs (task administration, screening).
- Collaborate with staff to submit protocols to the IRB; monitor protocol compliance.
- Develop and implement policies and procedures related to SNFA research.
- Provide recommendations on the implementation of all GCP and NIH policies and procedures.
- Work with staff on the training of OP4 nursing staff and others through observation and teaching of the psychological assessments (SCIDs).
- Maintain database in the use of Clinical Trials Database (CTDB) and the development of new databases in the Research Electronic Data Capture (REDCap).
- Collaborate with staff on the recruitment of research participants by speaking to community groups to increase program visibility.
- Provide clinical expertise to callers remotely, on the NIH IRP staff support line during the COVID 19 pandemic.
- Assists researchers with protocol development, assembly and review of clinical trial documents.
- Assist researchers prepare study reports and status updates, including amendments, audits and other administrative documentation.
- Assists researchers develop and maintain trial related documents and operational procedures.
- Assist researchers maintain accurate records of all protocols and study applications, safety reports, annual reports and correspondence.
- Maintains study databases and conducts basic analysis.
- Assist researchers track study requests and protocol approvals, maintaining a record of all submissions and status of approvals.
- Assists researchers collect, distribute and file regulatory documents.
- Assist researchers review and submit protocol actions for clearance within the NIH Protocol Tracking and Management System.
1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked
Certifications & Licenses
- Master’s degree in Life Sciences or other related discipline and three years experience
Field of Study
- Clinical Psychology
- Experience conducting research protocols with human subjects
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: firstname.lastname@example.org