Research Coordinator II - Research Management Office

• Writes protocol applications and consent forms for Institutional Review Boards. Prepares and submits required institution and federal documentation for the conduct of the trial.
• Manages regulatory issues for all programs upon receipt of IRB approval. This includes preparing any addenda and/or annual progress reports, submitting adverse event/safety information to the IRB, updating/maintaining regulatory requirements such as updated investigator CVs, changes in principal investigator, FDA form 1572, etc. Also, maintains accurate, regulatory-compliant program/study binders.
• Performs research on background material pertaining to the clinical trials and uses this research to complete all protocol submissions.
• Negotiates contracts and develops cost-per-patient study budgets.
• Coordinate's efforts of all agencies involved in the protocol approval process. Makes and maintains contacts within the pharmaceutical industry.
• If applicable: May include budgetary responsibility to include plan/forecast, prepare, approve, monitor.
• 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 Research Coordinator II to write, edit, document, and package protocols, consent forms and other regulatory documents for all assigned medical centers. Responsible for protocols from all sponsors (federal and non-federal) and completing all actions for the protocol to receive final IRB Approval.

This position will be in support of the Research Management Office (RMO), located at the Home Office in Bethesda, MD. This office provides scientific, technical, and programmatic support services to various domestic military sites in initiating and managing clinical research studies.

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.