The Henry M. Jackson Foundation for the Advancement of Military Medicine · 20 hours ago
Clinical Research Associate II - BEST
The Henry M. Jackson Foundation for the Advancement of Military Medicine is seeking a Clinical Research Associate II to support and manage all aspects of study implementation for the National Intrepid Center of Excellence and the Naval Medical Center Camp Lejeune. This role involves ensuring compliance with safety provisions and regulations while supporting research initiatives related to TBI and psychological health conditions.
Health CareMedicalMedical Device
Responsibilities
Submits protocol application and consent forms on behalf of PI to local Institutional Review Board (IRB). Ensures that all amendments, continuing reviews and adverse events have been submitted to the IRB
Ensures that regulatory documents are maintained and are up to date. Maintains accurate regulatory compliant program/study binders for each study. Responsible for updates and maintenance of regulatory requirements such as the investigator's CVs, changes in PI, FDA form 1572, training records, license etc
Performs qualification, initiation, monitoring, and closeout of study. Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and suggest actions to obtain compliance
Assures sufficient investigator qualifications, training, facility resources, laboratories, equipment, and staff to properly support studies. Ensures the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness
Performs research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring GCP are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements
Monitors and assesses the clinical research site's patient recruitment and retention success
Will work closely with Interventionists to support and provide back-up to participants when needed
May train Clinical Research Coordinator
Assist with budget
May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role
Qualification
Required
Master's Degree required, preferred in Social or Life Science
Minimum of 3 to 5 years experience required
Working knowledge of a broad range of medical specialties
Working knowledge of all applicable federal and military regulations regarding the use of human and animal subjects in research (e.g.: 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 314, 45 CFR 46, FDA Form 1571, and FDA Form 1572)
Familiarity with Institutional Review Board (IRB) processes and Institutional Biosafety Committee (IBC) procedures
Strong communication skills with the ability to collaborate effectively with individuals at all organizational levels
Ability to set priorities, manage multiple tasks, and consistently meet deadlines
U.S. Citizenship required; must be able to obtain and maintain a T3/Secret clearance
Ability to stand or sit at a computer for prolonged periods
Benefits
Medical, dental, and vision coverage
Health savings and retirement plans
And more.
Company
The Henry M. Jackson Foundation for the Advancement of Military Medicine
The Henry M.
Funding
Current Stage
Late StageTotal Funding
$2.2MKey Investors
BIRD FoundationTEDCOOrthopaedic Research and Education Foundation
2025-10-10Grant
2024-12-11Grant· $0.9M
2023-10-24Grant· $1.3M
Recent News
2025-12-03
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