Regulatory Affairs Coordinator (Open Rank: Senior – Principal)

About the position 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. 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 Requirements • Senior Professional: • Bachelor's degree from an accredited institution in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution • 2 years of related professional experience • Substitution A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis. • Principal Professional: • 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 • 3-5 years of related professional experience • Substitution: 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. • Ability to communicate effectively, both in writing and orally. • Ability to establish and maintain effective working relationships with employees at all levels throughout the institution. • Outstanding customer service skills. 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 • 1 year Project Management experience • 3 years of regulatory experience • 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). Benefits • Medical: Multiple plan options • Dental: Multiple plan options • Additional Insurance: Disability, Life, Vision • Retirement 401(a) Plan: Employer contributes 10%25 of your gross pay • Paid Time Off: Accruals over the year • Vacation Days: 22/year (maximum accrual 352 hours) • Sick Days: 15/year (unlimited maximum accrual) • Holiday Days: 15/year • Tuition Benefit: Employees have access to this benefit on all CU campuses • ECO Pass: Reduced rate RTD Bus and light rail service • There are many additional perks & programs with the CU Advantage.