Regulatory Affairs Coordinator (Open Rank: Senior – Principal)

Job Summary:

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.

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 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

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.

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:

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.

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

• 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.

• Outstanding customer service skills.

How to Apply:

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

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 April 15, 2026.

Anticipated Pay Range:

The starting salary range (or hiring range ) for this position has been established as:

Senior Professional:
$56,553-$71,936

Principal Professional:
$65,036-$85,726

The above salary range (or hiring range ) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu ​.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program .