Master's degree in General Medical and Health Services
CITI certification
Experience with Electronic Data Capture Systems
Strong background in clinical trial coordination
Proven ability to liaise with regulatory authorities
Experience in training clinical trial site staff
Previous involvement in clinical trial work
Responsibilities
Assist researchers with protocol development and clinical trial documentation
Maintain trial-related documentation and study databases
Collect and submit regulatory documents to the IRB and other bodies
Support participant recruitment and scheduling
Train staff and investigators on protocol submission processes
Generate and present bi-weekly updates on trial progress
Compile data for scientific or regulatory meetings
Benefits
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 for healthcare, parking, dependent care, and transportation
Full Job Description
Axle is seeking a Senior Research Associate 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)
Position Overview
The Senior Research Associate (Clinical Protocol Coordinator) will support the clinical and basic research programs of the Department of Perioperative Medicine in the NIH Clinical Center. Responsibilities include assisting researchers with protocol development and the assembly and review of clinical trial documents, maintaining trial-related documentation and study databases, collecting and submitting regulatory documents to the IRB and other regulatory bodies, supporting participant recruitment and scheduling, and training staff and investigators on protocol submission processes. A Master's degree is required, with General Medical and Health Services listed as the field of study. This position is based at the NIH campus in Bethesda, MD (Monday through Friday, 40 hours per week) and is telework eligible.
Additional Qualifications
Certifications & Licenses
Master's degree
CITI certification
Field of Study
General Medical and Health Services
Software
Electronic Data Capture System
Skills
Liaising with regulatory authorities
Training clinical trial site staff
Coordinating project meetings
Previous clinical trial work
Deliverables
Meet with lab members to present updates - Bi-Weekly
Present clinical updates to include patient enrollment, progress in trial, recruitment, data collection, and regulatory and clinical data - Bi-Weekly
Generate weekly reports outlining progress and status of ongoing activity - Weekly
Enter and oversee data storage in database - Ad-Hoc
Work with investigators to facilitate patients' care during clinical visits - Ad-Hoc
Meet and update investigators on the trial status and on protocol and regulatory updates - Ad-Hoc
Compile data and produce presentations for scientific or regulatory meetings - Ad-Hoc
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.
