Research Coordinator

Updated: September 9, 2019
Job ID: 215236
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking a Research Coordinator to support the Research Management Office located at the HJF Home Office in Bethesda, Maryland. 

The incumbent will be responsible for coordinating single and multicenter, industry and/or federally sponsored clinical trial projects at various Department of Defense Military Treatment Facilities.

Responsibilities: 

  1. Write protocol applications and consent form(s) for clinical trial projects. Prepare required institutional and FDA regulatory documentation for the conduct of the trial. Submit protocol application, consent form(s), and regulatory documentation for the Institutional Review Board’s (IRB) initial review of the project. Work with IRB reviewers to correct and refine submission to secure IRB approval.  
  2. Manage projects upon receipt of IRB approval. This includes preparing any modifications to the project 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, maintain accurate, regulatory-compliant project/study binders.
  3. Negotiate contracts with industry sponsors and develop cost-per-patient study budgets.
  4. Coordinate efforts of all agencies involved in the project’s IRB approval process. These include: Departments of Clinical Investigation, the project/study sponsor, the investigative study team, the National Institutes of Health, and various other agencies.  Make and maintain contacts within the pharmaceutical industry.
  5. Provide administrative support to the Principal Investigator, including participating in the initiation of investigative sites and serving as a general point of contact for the project/study.
  6. Perform other duties as needed.

Required Skills, Knowledge, and Abilities: Requires excellent interpersonal and communication skills; ability to work professionally and seamlessly with teammates, customers, and all parties involved in the clinical trial project; ability to coordinate multiple projects at once; ability to use sound judgement to independently interpret issues and determine best path forward; working knowledge of all applicable federal and military regulations regarding the use of human subjects in research; familiarity with medical terminology, working knowledge of a broad range of medical specialties, and a general understanding of clinical trial research processes. 

Minimum Education/Training Requirements: Bachelor’s degree required. CITI training and other required human subject research training will be provided. 

Minimum Experience: 0 - 2 years experience with IRB approvals and/or study start-up activities for clinical trial research protocols.

Physical Capabilities: Some lifting and walking.

Work Environment: Most of the work is done in a well-lighted, climate-controlled office. Visits to hospitals/clinics are required.

Background: U.S. Citizenship required; eligibility to obtain and hold a Secret Security 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, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.  

HJF is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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

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