Join the HJF Team !
HJF is seeking a Research Coordinator I to support the Research Management Office, located at the Home Office in Bethesda MD. HJF provides scientific, technical, and programmatic support services to the Research Management Office. US Citizenship is required.
Responsibilities are for coordinating multi-center industry and/or federally sponsored clinical trial projects at Department of Defense Principal Investigators (PI) at Military Treatment Facilities (MTFs). 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 site regulatory documentation for the PI/MTF, and negotiating business and data sharing agreements with the sponsor.
- Write protocol applications and consent form(s) for sponsored clinical trials. Prepare required institutional and FDA regulatory documentation. Submit protocol application, consent form(s), regulatory documentation, and sponsor documentation for the IRB’s initial review of the trial. Work closely with the MTF’s Department of Research Programs and IRB reviewers to refine the submission and secure initial IRB approval.
- Manage clinical trials upon receipt of initial IRB approval. This includes preparing and coordinating approval of the following IRB submissions: modifications to the protocol or study personnel, annual progress reports, adverse event reports/new safety information, and study closure reports. Also, maintain accurate and compliant regulatory documentation required from the PI/MTF by the sponsor.
- Negotiate business agreements with sponsors including Non-Disclosure Agreements, Clinical Trial Agreements, and cost-per-patient study budgets. Coordinate completion of Data Sharing Agreements.
- Coordinate efforts of all agencies involved in the study start-up process and conduct of the clinical trial. These include the MTF’s Department of Research Programs, IRB, sponsor and its agents, PI and other study personnel at the MTF, financial analysts, and various other agencies. Make and maintain contacts within the pharmaceutical industry.
- Provide administrative support to the PI, including participating in the initiation of investigative sites and serving as a general point of contact for the study.
- 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:
- Requires excellent interpersonal and communication skills; ability to coordinate multiple projects at once; ability to set and meet deadlines; use sound judgement to independently interpret issues and determine best path forward.
- Working knowledge of a broad range of medical specialties and familiarity with medical terminology.
- General understanding of clinical research processes.
- Working knowledge of all applicable federal and military regulations regarding the use of human subjects in research (e.g. 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, 45 CFR 46, FDA Form 1572) preferred.
- Familiar with Institutional Review Board activities and Institutional Biosafety Committee actions 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.