Subject: Entry Level Research Coordinator Position!
Great opportunity for May 2018 Grad looking to use Science background in
HJF is seeking a Research Coordinator to support the Clinical Trials
Department at HQ in Bethesda, MD.
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
4. Coordinate efforts of all agencies involved in the project’s IRB
approval process. These include: the MTF’s Department of Clinical
Investigations and IRB, 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.
Required Skills, Knowledge, and Abilities: Requires excellent interpersonal
and communication skills; ability to work professionally and seamlessly with
customers, and all parties involved in the clinical trial project; ability to
coordinate multiple projects at once; 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
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 projects.
Physical Capabilities: Some walking
Work Environment: Most of the work is done in a well-lighted,
climate-controlled office. Visits to hospitals/clinics are required.
Any qualifications to be considered to be equivalents, in lieu of stated
minimums, require the prior approval of the Chief Human Resources Officer
Contact Person: Nicole Mazzella
Contact Email: [log in to unmask]