Bethesda, Maryland

Join the HJF Team !

HJF is seeking a Research Coordinator I to support the Research Management Office (RMO), located at the Home Office in Bethesda MD. HJF RMO provides scientific, technical, and programmatic support services to various domestic military sites. US Citizenship is required.

Responsibilities are to coordinate multi-center industry and/or federally sponsored clinical trial projects for Principal Investigators (PI) at military sites. Act as the central point of contact during study start-up procedures and throughout the life of the clinical trial by preparing submissions to the Institutional Review Board (IRB), filing and maintaining study documentation, and negotiating business and data sharing agreements with the sponsor.

  1. Write protocol applications and consent form(s) for sponsored clinical trials. Prepare required regulatory documentation. Submit protocol application, consent form(s), regulatory documentation, and sponsor documentation for initial IRB review. Work closely with the IRB office to refine the submission and secure approval.
  2. Manage clinical trials upon receipt of initial IRB approval. This includes preparing and coordinating the following IRB submissions: modifications to the protocol, annual progress reports, adverse event reports/new safety information, and study closure reports. Also, maintain complete and organized study files.
  3. Negotiate business agreements with sponsors including Non-Disclosure Agreements, Clinical Trial Agreements, and cost-per-patient study budgets. Coordinate completion of Data Sharing Agreements.
  4. Coordinate efforts of all agencies involved in the study start-up process and conduct of the clinical trial. These include the PI and other research staff, IRB, sponsor, and financial analysts. Make and maintain contacts within the pharmaceutical industry.
  5. Provide administrative support to the PI, including participating in sponsor site visits and serving as a general point of contact for the study.
  6. 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.

Required Knowledge, Skills and Abilities:
  • Entry-level candidates with the following required skills/abilities are encouraged to apply: Excellent interpersonal and communication skills; ability to coordinate multiple projects at once; ability to set and meet deadlines; ability to independently interpret issues and determine best path forward.
  • Working knowledge of a broad range of medical specialties and familiarity with medical terminology preferred.
  • General understanding of clinical research processes preferred.
  • Some knowledge of applicable federal and military regulations regarding the use of human subjects in research preferred.
  • Some familiarity with IRB activities preferred.

Minimum Education: Bachelor's degree is required.

Minimum Experience/ Training Requirements: 0-5 years of relevant work experience required.

Work environment:Set in an office work environment. Visits to hospitals/clinics are required.

Background/Security:U.S. citizenship required; eligible to obtain and maintain a Tier III Investigation/ Secret Clearance and Common Access Card (CAC).

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, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Bethesda, Maryland

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is a global organization dedicated to advancing military medical research. 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.

The not-for-profit Foundation is authorized by Congress to support research at the Uniformed Services University of the Health Sciences (USU) and throughout military medicine. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. The Foundation’s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and to accomplish their research goals effectively and efficiently.

Similar jobs