The Department of Ophthalmology has an immediate opening for a full-time Research Services Senior-Principal Professional (open rank)-Regulatory Affairs Coordinator. The position will independently maintain and manage all IRB and regulatory processes for department research studies. Primary duties will include, but not be limited to: submissions to the Institutional Review Board (IRB) of record including amendments, unanticipated problems, continuing reviews, and study closures; maintenance of the investigator site file/regulatory binder and all essential documents including documentation of appropriate training and delegation for all personnel; submissions to internal University and Hospital research portals; acting as primary regulatory contact person for sponsors/Contract Research Organizations (CROs)/coordinating centers; maintaining research credentials, training documentation and licenses; The Regulatory Affairs Coordinator will work closely with the Director of Clinical Research, program managers, and clinical research coordinators.
Key Responsibilities:
Prepare, submit, and manage regulatory documents for IRB submissions (COMIRB, Advarra, etc), including initial submissions, continuing reviews, amendments, reportable events, and study closures.
Coordinate regulatory documentation for multi-site and industry-sponsored clinical trials.
Maintain complete and audit-ready regulatory binders in accordance with institutional, sponsor, and regulatory requirements.
Ensure compliance with ICH-GCP, FDA regulations, institutional policies, and sponsor requirements.
Track and maintain investigator qualifications, including CVs, medical licenses, training documentation, and financial disclosures.
Assist with protocol and consent form development
Assist investigators and study teams with regulatory start-up activities, including feasibility documentation and site qualification materials.
Maintain investigator site files (ISF) and ensure all required documents are current and complete.
Prepare regulatory documentation for monitoring visits, sponsor audits, and regulatory inspections
Assist with regulatory reporting of adverse events, unanticipated problems, and protocol deviations as required by IRB and sponsors
Work closely with investigators and study teams to ensure regulatory compliance for specialized ophthalmology research protocols
Develop and maintain regulatory tracking systems for submissions, approvals, and expiration dates.
Other tasks as assigned
Work Location: Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.