Clinical Research Coordinator II - TraCR

• Assists human subjects' research activities, to include clinical trial protocol development, study operational procedures and forms development, and study implementation within the NMRC CTC in conjunction with senior staff.
• Prepares and submits regulatory documents, including scientific and institutional review board submissions.
• Recruits and screens new subjects for participation in clinical research studies occurring in the NMRC CTC.
• Reviews new patient records and screens patients for eligibility in participation of research protocol.
• Interviews patients for protocols and collects and analyzes appropriate data for recruitment purposes, determine patient commitment and obtains informed consent. Educates patients about the research protocol, their roles in the protocols, and any other vital information.
• Monitors study progress and identifies and resolves/reports issues, including protocol deviations and non-compliance, to the appropriate parties.
• Monitors, documents, and reports adverse events and safety concerns in accordance with regulatory and sponsor requirements.
• Collects, organizes, catalogs, disseminates, and maintains appropriate files of current data. Maintains weekly/monthly status reports on all patients.
• Acts as a liaison between patients and physicians and serves as a resource for the patients.
• Transcribes and resolves queries of data in case report forms (hardcopy or electronic) and prepares documents, under direction of project heads.
• Adheres to legal, professional and ethical codes with respect to confidentiality and privacy. Assures that protocol requirements are achieved within Good Clinical Practices.
• Schedules patients for appointments and visits. Assists with monitoring audits/visits for protocols.
• Trains and mentors junior research staff as needed.
• Travels from their assigned workplace to support protocols at other sites as needed.
• 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.

Join the HJF Team!

HJF is seeking a Clinical Research Coordinator II to assist in the conduct of clinical research in conjunction with one or more specified clinical research protocols. Developing adherence to legal, professional, and ethical codes with respect to confidentiality and privacy helps ensure that protocol requirements are achieved in accordance with Good Clinical Practice. This is the second of four levels for the Clinical Research Coordinator (CRC) series.

This position will be in support of the Translational and Clinical Research Department (TraCR) within the Infectious Diseases Directorate (IDD) at the Naval Medical Research Command (NMRC). The incumbent is tasked with supporting and conducting high-quality translational and clinical research to facilitate the development of infectious disease countermeasures for US military personnel. Within the Directorate is the NMRC Clinical Trials Center (CTC), a 3,500 square foot state-of-the-art facility located in Bethesda, MD that is equipped to conduct Phase 1 and 2 outpatient clinical trials. The NMRC CTC evaluates vaccines, therapeutics, prophylactics, and medical devices in human subjects to suitably advance innovative products from the laboratory to the front line and maximize the medical readiness of the Warfighter. This position will work within the NMRC CTC to support those clinical trial activities.

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.