Research Services Intermediate-Principal Professional – Regulatory Affairs Coordinator

University of Colorado•Hybrid, CO

21d•$57,525 - $95,833•Hybrid

About The Position

The Department of Ophthalmology at the University of Colorado Anschutz Medical Campus is hiring a full-time, open-rank Regulatory Affairs Coordinator. The position independently maintains and manages IRB and regulatory processes for departmental research studies, including submissions to the IRB of record, regulatory documentation, investigator site files, and research credentials. The coordinator serves as a primary regulatory contact for sponsors, Contract Research Organizations, and coordinating centers, and works closely with the Regulatory Affairs Program Manager, Director of Clinical Research, program managers, clinical research coordinators, and investigators. The role supports investigator-initiated and industry-sponsored clinical trials and specialized ophthalmology research protocols. It ensures that regulatory records are current, complete, and audit-ready, and that studies comply with applicable institutional, sponsor, ICH-GCP, and FDA requirements. The position is hybrid, with three days per week on campus and additional in-person attendance as needed after onboarding and training. The Department of Ophthalmology is housed in the Sue Anschutz-Rodgers Eye Center on the Anschutz Medical Campus. Its mission is to be a nationally recognized department through exemplary patient care, educational leadership, innovative research, and high ethical standards.

Requirements

Bachelor's degree from an accredited institution and at least 1 year of professional experience in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field for the Intermediate Professional level.
For the Senior Professional level, a bachelor's degree and at least 2 years of relevant professional experience.
For the Principal Professional level, a bachelor's degree and 3–5 years of relevant professional experience.
A combination of education and related technical, military, or paraprofessional experience may substitute for a bachelor's degree on a year-for-year basis.
Ability to communicate effectively in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Ability to maintain excellent organization across a variety of regulatory functions.
Outstanding customer service skills.

Nice To Haves

Master’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field.
Experience in ophthalmology and/or clinical research.
Experience with eRegulatory software such as Advarra, Veeva, Florence, or CRIO.
One year of project management experience.
Three years of regulatory experience.
IRB experience with 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, including COMIRB, UCHealth Research Administration, OnCore, REDCap, or InfoEd.

Responsibilities

Prepare, submit, and manage IRB regulatory documents, including initial submissions, continuing reviews, amendments, reportable events, and study closures.
Coordinate regulatory documentation for investigator-initiated trials and industry-sponsored clinical trials.
Maintain complete, current, and audit-ready regulatory binders and investigator site files 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 informed consent form development.
Assist investigators and study teams with regulatory start-up activities, including feasibility documentation and site qualification materials.
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 IRBs and sponsors.
Work with investigators and study teams to ensure regulatory compliance for specialized ophthalmology research protocols.
Develop and maintain systems for tracking submissions, approvals, and expiration dates.
Maintain research credentials, training documentation, licenses, and required personnel training and delegation records.
Serve as a primary regulatory contact for sponsors, Contract Research Organizations, and coordinating centers.
Submit materials to internal University and Hospital research portals.
Perform other tasks as assigned.