Regulatory Affairs Coordinator

• Assists with the review of protocols, grants, contracts, clinical trials and other research activities to ensure compliance with relevant federal and local regulations and polices of research involving human subjects, laboratory animals, select agents, utilization of recombinant DNA and HIPAA.
• Assists with maintaining a regulatory database and tracking database to include data entry, queries, and reports.
• Ensures required protocols are registered and up to date in clinicaltrials.gov.
• Reviews research personnel training for assigned portfolio to ensure that participating personnel have received appropriate training in human subjects research protection, HIPAA, animal research protection, Good Clinical Practices, conflicts of interest in research, responsible conduct in research, and shipping dangerous goods have been completed.
• Maintains effective relationship with research staff, Principal Investigators and Institutional Review Boards' (IRBs) regulatory personnel, and others to ensure continued scientific operational functioning of protocols in assigned portfolio.
• Monitors publications and website information from federal regulatory agencies to gain current information concerning changes in regulatory policy.
• Review and process research participant travel and reimbursement and request for clincards.
• Assists with completion of documents related to regulatory submissions for assigned portfolio and ensures they are submitted prior to their respective deadlines.
• 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 Regulatory Affairs Coordinator to be responsible for assisting in the compliance of HJF research programs with applicable local, state and federal regulations for human subjects research, animal use research, recombinant DNA, and Health Insurance Portability and Accountability Act (HIPAA). This is the first level in the Regulatory Affairs series.

This position will be in support of the Clinical Regulatory Affairs & Compliance Office at HJF Home Office in Bethesda, MD.

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.