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Program Coordinator, Institutional Review Board - Georgetown University Medical Center
On behalf of Georgetown University, the Institutional Review Board's (IRB) primary role is to safeguard the rights and welfare of all human subjects who participate in research studies conducted by Georgetown.
The Program Coordinator coordinates the operation of the Institutional Review Board (IRB), specifically, the Pediatric Oncology and Biomedical IRB (Committee A) with the IRB Director. S/he is the primary liaison with the IRB reviewing research conducted at Georgetown University and affiliate institutions. The incumbent administratively pre-reviews IRB submissions (new studies, amendments, continuing reviews, reportable events) prior to IRB review to make sure that all regulatory and institutional requirements have been met. Duties include but are not limited to:
Make determinations regarding level of review required, and assign reviews to appropriate IRB members and IRB meetings.
Facilitate process to execute Institutional Authorization Agreements and Individual Investigator Agreements.
Verify that all institutional conflict of interest processes have been implemented, and that any conflict management plans are implemented appropriately.
Verify if all the research members interacting with human subjects or having access to identifiable information have completed and renewed, when required, human subjects protection and HIPAA training.
Verify that any applicable ancillary committee reviews and approvals have been completed prior to IRB review (Conflict of Interest, Protection of Minors, HIPAA Waivers, Radiation Safety Committee, Scientific Review).
Schedule, organize and facilitate all full board Committee A meetings. Responsible for correspondence to investigators regarding all IRB actions.
Complete minutes for all Committee A meetings.
Point of contact for the research community and IRB members for education on the IRB electronic system, IRB processes, regulations, and institutional policy regarding research and the IRB.
Assist with quality assessments of the IRB processes and electronic system, provide solutions for improvement, and assist in implementation of improvements/changes.
Respond to study participants' concerns; submit the study participants' concerns to the Director of IRB.
Assist with review, creation and implementation of IRB policies and procedures.
Requires 4 years of experience to acquire skills necessary to carry out administrative activities
Previous work experience in an IRB Office
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EEO Statement: Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law.