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.