Regulatory Affairs Coordinator (Open Rank: Senior-Principal)

University of Colorado

5d•Hybrid

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.

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).

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