Regulatory Affairs Coordinator (Open Rank: Senior-Principal)

University of Colorado Anschutz Medical Campus 

Department: Ophthalmology

Job Title: Regulatory Affairs Coordinator (Open Rank: Senior-Principal)

Position #00846414 – Requisition #39535

Job Summary:

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.

Why Join Us:

The Department of Ophthalmology is housed in the Sue Anschutz-Rodgers Eye Center on the Anschutz Medical Campus. This state-of-the-art facility is one of the largest eye centers in the country and serves not only patients in the Rocky Mountain region but also patients all over the world.