Research Coordinator II - Regulatory Affairs

About the 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.

Responsibilities

• 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, including preparing 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.
• 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.
• Coordinates efforts of all agencies involved in the protocol approval process and 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, including attendance of and participation in required training for the role.

Qualifications

• Bachelor's Degree in a related scientific field required.
• Minimum of 3‑5 years experience required.
• At least 1‑2 years of clinical research experience preparing IRB submissions strongly preferred.
• 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).
• Must be familiar with Institutional Review Board activities and Institutional Biosafety Committee actions.
• Must be able to set and meet deadlines.
• US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.
• Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable.
• Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Work Environment

This position will take place primarily in an office/laboratory setting.

Compensation

The hourly pay range for this position is $29.33‑$40.87. Actual hourly pay will be determined based on experience, education, etc.

Benefits

HJF offers a comprehensive suite of benefits focused on your health and well‑being, from medical, dental, and vision coverage to health savings and retirement plans, and more.