Infectious Disease Research Nurse Coordinator

Updated: November 5, 2019
Job ID: 215369
Status: Full-Time
Regular/Temporary: Regular
Location: Bethesda, MD, United States

Join the HJF Team!

HJF is seeking an Infectious Disease Research Nurse Coordinator to support the Pediatrics Department located at the Uniformed Services University (USU) in Bethesda, MD. HJF provides scientific, technical and programmatic support services to the Pediatrics Department. 

The incumbent will 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 for the protocol to receive final IRB Approval.

Responsibilities: 

  1. Write protocol applications, consent forms and recruitment documents, advertisements and plans 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 investigators and status, 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.
  6. Perform research activities in support of clinical trials to include obtaining informed consent, documentation on source and case report forms, obtaining vital signs and venipuncture.  
  7. Performs other duties as assigned.

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 14. 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. Ability to perform venipuncture and other minimally invasive procedures on pediatric patients. 

Minimum Education/Training Requirements: Bachelor’s degree

Minimum Experience: 4+ years’ experience working on clinical trials; 2+ years’ experience working with pediatric patients either in research or clinical practice.

Required Licenses, Certification or Registration: RN strongly preferred, Research Coordinator certification preferred.

Supervisory Responsibilities/Controls: N/A

Work Environment: Office/laboratory environment.

Background: Eligibility to obtain a Common Access Card (CAC); eligibility to obtain and hold a Public Trust background.

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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