Research Coordinator II

Updated: August 11, 2017
Job ID: 213137
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Come Work at HJF!

HJF is seeking a Research Coordinator II to support the Audiology and Speech department located at Walter Reed National Medical Center (WRNMMC) in Bethesda, Maryland. HJF provides scientific, technical and programmatic support services to WRNMMC. Responsibilities are to write, edit, document, and package protocols, consent forms and other regulatory documents for all Medical Centers assigned. The Research Coordinator is responsible for protocols from all sponsors (Federal and Non Federal) and completing all actions in order for the protocol to receive final IRB Approval.

Responsibilities:                                                                       

  1. Write protocol applications and consent forms for Institutional Review Boards. Prepare and submit required institution and FDA documentation for the conduct of the trial.
  2. Manage regulatory issues for all programs 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, maintain accurate, regulatory-compliant program/study binders.
  3. Performs research on background material pertaining to the clinical trials and uses this research to complete all protocol submissions.
  4. Negotiate contracts and develop cost-per-patient study budgets.
  5. Coordinate efforts of all agencies involved in the protocol approval process. These include: Departments of Clinical Investigation, the program/study sponsor, the National Institutes of Health, and various other agencies. Make and maintain contacts within the pharmaceutical industry.

JOB SPECIFICATIONS:

Required Knowledge, Skills, and Abilities: 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.

Minimum Education/Training Requirements: Bachelor’s degree

Minimum Experience: 4-6 years’ experience working with an IRB and protocol related writing and editing

Work Environment: office/laboratory environment

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 Director of Human Resources.

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