Research Services Intermediate-Principal Professional – Regulatory Affairs Coordinator

Job Summary:

The Department of Ophthalmology has an immediate opening for a full-time Research Services Intermediate-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 Regulatory Affairs Program Manager, Director of Clinical Research, other program managers, clinical research coordinators, and Investigators.

Key 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 Investigator-Initiated Trials (IITs) 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.

Work Location:

Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings after onboarding/training period are complete.

Why Join Us:

The Department of Ophthalmology is housed in the Sue Anschutz-Rodgers Eye Center on the Anschutz Medical Campus. This state-of-the-art facility is one of the largest eye centers in the country and serves not only patients in the Rocky Mountain region but also patients all over the world.

The technological innovations conceived and developed by departmental faculty have changed the practice of eye care throughout the world. Our educational programs train the next generation of leaders in ophthalmology. Our specialists have developed national and international reputations for excellence in routine and complex ophthalmic care. We have invested heavily in tracking our clinical outcomes and we are proud that our clinicians perform at the highest levels in their respective fields.

The mission of the Department of Ophthalmology is to be a nationally recognized department of ophthalmology by providing exemplary patient care founded on educational leadership, innovative research, and high ethical standards.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options

• Dental: Multiple plan options

• Additional Insurance: Disability, Life, Vision

• Retirement 401(a) Plan: Employer contributes 10% 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.

Qualifications:

Minimum Qualifications:

Intermediate Professional:

• Bachelor's degree from an accredited institution and 1 year of professional experience in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution

  • A combination of education and related mechnical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.

Senior Professional:

• Bachelor's degree from an accredited institution and 2 years of professional experience in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution

  • 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 from an accredited institution and 3-5 years of professional experience public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution.

  • 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.

Preferred Qualifications:

• 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.

• Experience with eRegulatory software (Advarra, Veeva, Florence, CRIO)

• 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).

Knowledge, Skills and Abilities:

• 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.

• Ability to maintain excellent organization across a variety of regulatory functions.

• Outstanding customer service skills.

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Ashley Woodhouse ashley.woodhouse@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by October 31, 2026