Subject: Entry Level Research Coordinator Position! Description: Great opportunity for May 2018 Grad looking to use Science background in non-lab setting! HJF is seeking a Research Coordinator to support the Clinical Trials Department at HQ in Bethesda, MD. 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: 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. Job Specifications: 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; 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 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]