What are the responsibilities and job description for the IRB Coordinator - Surgery position at uic?
The Department of Surgery at the University of Illinois Chicago is seeking to fill an IRB Coordinator position.
Position Summary
The IRB Coordinator provides regulatory expertise, guidance, and administrative support to the Department of Surgery Research Director Institutional Review Board (IRBs). Attains and maintains comprehensive and up-to-date knowledge of human subject research protections and IRB operations including new or revised regulations and guidance issued by the Office for Human Subject Protections (OHRP), the Food and Drug Administration (FDA), the State of Illinois, and other regulatory agencies as applicable. Serves as a subject matter expert providing guidance and training to researchers, faculty, staff, students.
Duties & Responsibilities
• Serve as a subject matter expert by educating, consulting, and guiding researchers, faculty, staff, and students in the design and conduct of human subject research to ensure compliance with federal and state regulations and UIC policy. Advise and assist research personnel in preparing research protocols and subsequent submissions for IRB review.
• Attain and maintain comprehensive and up-to-date knowledge of human subject research protections and IRB regulations as contained in 45 CFR 46, 21 CFR 50 & 52, and other applicable federal and state regulations.
• Educate and guide staff members on the federal and state regulations and UIC policies governing human subject research.
• Prepare research protocol submissions to ensure that individual research protocols involving human subjects are in compliance with federal regulations, state laws and University policies and procedures for conducting research. Independently conducts and document administrative and regulatory reviews within the context delegated by the IRB chair.
• Compose reply letters that accurately communicate and document the determinations, describing any/all revisions required by the PI in order to secure IRB approval.
• Maintain IRB-required record keeping and prepare correspondence to UIC investigators, study sponsors, and regulatory agencies that document the determinations of the IRB.
• Protocol Management:
• Coordinate the readiness of clinical research trials by overseeing the study activation process (form and support sponsor relationships, ensure the receipt of documents and supplies, secure initial PRC (Protocol Review Committee) and IRB (Institutional Review Board) approval and, if required, FDA application approval, and activate the study in a timely manner per institutional guidelines).
• Assist in the close-out of each trial, ensuring the completion of all clinical, data management, investigational pharmacy, and regulatory tasks, followed by the proper archiving of study documents.
• Collaborate with Principal Investigators, clinicians, research staff, and other institutional officials to continually assess the clinical research trial portfolio and suggest adjustments when necessary.
• Ensure proper reporting of serious adverse events and protocol modifications as required by the UIC IRB, the National Cancer Institute’s Central IRB, the Cancer Center’s Protocol Review Committee, the FDA, and grant sponsors; notify and inform physicians, clinical and research staff, and applicable affiliates of the impact on the research and patients enrolled at UIC.
• Assist in maintenance ClinicalTrials.gov entries for trials managed by the OCTO.
• Supervisory & Collaboration:
• Coordinate and oversee the conduct of clinical protocols by supervising all regulatory staff, including student employees when applicable.
• Establish and facilitate relationships with clinicians, staff, and community resources to ensure research needs are being met within the Department of Surgery.
• Keep current on legislation, rules, regulations, procedures, and development; educate physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients.
• Monitor project developments on an ongoing basis. Propose and implement change
