Research Coordinator II - RMO

Overview

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. Specifically responsible for study start-up activities and regulatory management of industry sponsored, FDA regulated clinical trials.

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.

• 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 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 study start-up process. Makes and maintains contacts within the pharmaceutical industry.
• 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.

• Bachelor's Degree in a science related field.
• Minimum of 3-5 years experience required. At least 1-2 years of clinical research experience preparing IRB submissions strongly preferred.

• Clinical research experience required, especially with FDA regulated clinical trials and IRB submissions.
• Working knowledge of a broad range of medical specialties and familiarity with medical terminology required.
• Working knowledge of all applicable federal and military regulations regarding the use of human subjects in research required (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 have excellent interpersonal and communication skills, be able to set and meet deadlines, coordinate multiple projects at once, and independently interpret issues and determine the best path forward.
• US Citizenship and the ability to obtain and maintain a T3/Secret Clearance.

• Ability to stand or sit at a computer for prolonged periods.

• This position will take place primarily in an office setting.

• The hourly pay range for this position is $29.33-$40.86. Actual hourly pay will be determined based on experience, education, etc.

• 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.

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…