Regulatory Affairs Program Manager

University of Colorado•Aurora, CO

6d•Hybrid

About The Position

The Department of Ophthalmology has an immediate opening for a full-time Research Services Program Manager-Regulatory Affairs Program Manager. 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 including SARC, Oncore, InfoEd and others; acting as primary regulatory contact person for department faculty and research staff, 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.

Requirements

Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution and 4-6 years of professional experience related to regulatory affairs in research administration.
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
Applicants must meet minimum qualifications at the time of hire.

Nice To Haves

Master’s degree in in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution
Experience working with in ophthalmology and/or clinical research
IRB experience (COMIRB or central IRBs, such as WCG or Advarra)
Experience drafting and editing study protocols and informed consent documents.
Experience with University of Colorado/UCHealth systems (Colorado Multiple Institutional Review Board, UCHealth Research Administration, Oncore, RedCap and InfoED).

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 industry-sponsored clinical trials and investigator-initiated studies for all clinical research in Ophthalmology
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
Develop, implement, and maintain departmental SOPs, templates, guidance documents, and regulatory workflows.
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, as well as staff training.
Lead and mentor regulatory coordinators and other research staff.
Collaborate with departmental leadership on strategic growth opportunities, process optimization, and operational enhancements.