Clinical Research Associate II

Overview

HJF is seeking a Clinical Research Associate II to support and manage all aspects of study implementation for the National Intrepid Center of Excellence (NICoE) and the Naval Medical Center Camp Lejeune (NMCCL). They will ensure that all necessary steps are taken towards safety provisions and all regulations are adhered.

This position supports research at both the National Intrepid Center of Excellence (NICoE) in Bethesda, Maryland, and the Naval Medical Center Camp Lejeune (NMCCL) in Camp Lejeune, North Carolina. The NICoE is a state-of-the-art facility established to advance national understanding of the visible and invisible wounds associated with TBI and related psychological health conditions. Its capabilities enable the evaluation and treatment of highly complex clinical, psychological, and social challenges, particularly in patients who continue to experience significant functional impairment despite intensive treatment.

As part of the Walter Reed National Military Medical Center (WRNMMC), the NICoE contributes to a military treatment facility known for excellence in TBI and brain health clinical care, research, and education.

The Naval Medical Center Camp Lejeune (NMCCL) provides primary medical care to Service Members and their families stationed at Camp Lejeune and Marine Corps Air Station New River. The Center offers integrated and mission-aligned medical support for Marines and Sailors, with the capability and capacity to care for higher-acuity patients. This enhances Navy Medicine’s overall readiness mission and strengthens its commitment to serving the Navy and Marine Corps team.

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners.

HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.

• 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.

• 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
• This position will take place…