Research Irb Coordinator

At Sinai Health System d/b/a Sinai Chicago, we take health care personally. Excellence in health care is about more than just medicine, technology, tests, and treatments, it is about really caring for people with dignity and respect. That is what we do. We are dedicated to providing the best care to meet the needs of people, for our community, for our patients and for you.

The IRB Coordinator manages the day-to-day administrative, regulatory, and educational operations of the Mount Sinai Hospital Institutional Review Board (MSH-IRB) using the Cayuse cloud-based human subjects protection/IRB module. The Coordinator ensures that all human subjects research protocols are reviewed and approved in compliance with federal regulations (45 CFR 46, 21 CFR Parts 50, 56, 312, and 814), applicable ICH-GCP guidelines, and MSH-IRB and related institutional policies.

The Coordinator provides expert regulatory guidance to investigators and research staff, supports the full Board and expedited/exempt review processes, and serves as the primary liaison among researchers, IRB Board members, and federal regulatory authorities. The coordinator will assist, if appropriate, the RTO Manager and or CRO-provided investigators and trials staff in communications/coordination with central IRBs or trial sponsors.

• Reviews and processes initial protocol submissions, amendments/modifications, continuing review applications, adverse event/unanticipated problem reports, protocol deviations for completeness and regulatory compliance, and closures prior to IRB consideration.
• Determines an appropriate review pathway (exempt, expedited, or full board) in accordance with 45 CFR 46 and 21 CFR Part 56 criteria, consulting with the IRB Chair as needed.
• Using the Cayuse platform, prepares and distributes Board meeting agendas, primary reviewer assignments, and protocol packets; record accurate and complete IRB meeting minutes reflecting determinations, required modifications, and stipulations.
• Issues IRB approval letters, stipulation response letters, and continuing review correspondence in compliance with applicable regulatory deadlines and institutional templates.
• Maintains a master tracking system for all active protocols, approval expirations, renewal due dates, and outstanding stipulations to ensure no lapses in IRB coverage.

• In conjunction with the RTO Manager, reviews informed consent documents (ICDs) and assent forms for pharmaceutical trials or medical device studies, and federally funded trials research to ensure compliance with 21 CFR Part 50, 45 CFR 46.116–117, and ICH E6(R3) standards.
• In non-trial research, reviews informed consent documents (ICDs) and assent forms to ensure compliance with MSH-IRB rules and applicable federal rules.
• Evaluates consent documents for readability, appropriate language, required elements, and suitability for Sinai’s diverse patient populations, including non-English-speaking and low-literacy participants.
• Manages HIPAA Authorization review processes and research waivers and authorizations in Cayuse.
• Ensures vulnerable population protections (prisoners, children, pregnant women, cognitively impaired individuals) are appropriately addressed if included in protocols.

• Serves as the institutional IRB point of contact regarding protocol questions, IRB submission requirements, and approval timelines for pharmaceutical sponsors, contract research organizations (CROs), and medical device manufacturers, consulting with the IRB Chair or the RTO Manager where appropriate.
• Supports FDA-regulated IND and IDE trials by ensuring IRB processes align with 21 CFR Parts 312 and 814 requirements, including sponsor notifications, safety reporting, and FDA correspondence.
• Coordinates with the Research Trials Office (RTO) on their study activation timelines, protocol-specific training requirements, and regulatory binder maintenance.
• Supports the RTO Manager with Clinical Trials.gov registration obligations in coordination with PIs and OGGA/RTO leadership/management to…