Regulatory and Compliance Coordinator

CU Denver; Aurora (CO); Hybrid; USD 72,000 - 91,000; Full time

Job summary

The University of Colorado Anschutz Medical Campus Division of Cardiology seeks a Regulatory and Compliance Coordinator to serve as a principal regulatory resource for a diverse portfolio of clinical studies. This role supports investigators and teams through feasibility, start-up, oversight, amendments, inspections, and closeout.

You will oversee IRB submissions, FDA-related documentation, and maintain inspection-ready files.

Qualifications

• Bachelor's degree from an accredited institution. Substitution: a combination of education and related experience may be substituted on a year-for-year basis.
• Three (3) years of clinical research, academic research support, or related experience with at least one (1) year as a subject matter expert and/or team lead.

Responsibilities

• Prepare and manage IRB submissions, including initial reviews, continuing reviews, amendments, reportable events, and study closures.
• Coordinate FDA-related regulatory documentation and submissions, as applicable, and ensure compliance with ICH-GCP, institutional policies, and sponsor requirements.
• Maintain accurate, current, inspection-ready regulatory binders and investigator site files, including investigator credentials, training, and disclosures.
• Lead regulatory start-up and closeout activities; coordinate site qualification and initiation visits and support sponsor monitoring, audits, and inspections.
• Partner with investigators and research staff on protocol, consent-form, feasibility, and regulatory documentation needs.
• Develop and improve SOPs, tracking tools, workflows, and training materials; provide regulatory guidance and mentorship across the research team.
• Collaborate with clinical research leadership to monitor trial workload, coordinate priorities, and provide operational oversight when needed.

Skills

Project management

Regulatory knowledge

Analytical skills

Written and verbal communication

Relationship management

Customer service

Medical terminology

Regulatory interpretation

Education

Bachelor's degree

Master's degree (preferred)

Job description

University of Colorado Anschutz Medical Campus

Department: Medicine - Division of Cardiology

Job Title: Regulatory and Compliance Coordinator

Position #: 00804856 - Requisition #: 41659

Job Summary

Join the University of Colorado Anschutz Division of Cardiology as a Regulatory and Compliance Coordinator, serving as a principal-level regulatory resource for a diverse portfolio of clinical research studies. This position supports investigators and research teams across the clinical trial lifecycle, from feasibility and study start-up through ongoing oversight, amendments, inspections, and closeout. The successful candidate will help protect research participants, maintain high-quality regulatory records, and support timely, compliant study execution.

Working closely with the Clinical Trial Medical Director, Clinical Trial Program Manager, principal investigators, institutional review boards, sponsors, and clinical partners, this professional will lead complex regulatory coordination, strengthen standard operating procedures, mentor team members, and contribute to continuous process improvement.

Key Responsibilities

• Prepare and manage IRB submissions, including initial reviews, continuing reviews, amendments, reportable events, and study closures.
• Coordinate FDA-related regulatory documentation and submissions, as applicable, and ensure compliance with ICH-GCP, institutional policies, and sponsor requirements.
• Maintain accurate, current, inspection-ready regulatory binders and investigator site files, including investigator credentials, training, and disclosures.
• Lead regulatory start-up and closeout activities; coordinate site qualification and initiation visits and support sponsor monitoring, audits, and inspections.
• Partner with investigators and research staff on protocol, consent-form, feasibility, and regulatory documentation needs.
• Develop and improve SOPs, tracking tools, workflows, and training materials; provide regulatory guidance and mentorship across the research team.
• Collaborate with clinical research leadership to monitor trial workload, coordinate priorities, and provide operational oversight when needed.

Work Location

Hybrid - this role is eligible for a hybrid schedule of 3-4 days per week on campus and as needed for in‑person study activities, meetings, and regulatory visits.

Why Join Us

The Division of Cardiology offers the opportunity to contribute to clinical research that advances cardiovascular care. You will work alongside investigators, research professionals, and institutional partners on studies that require thoughtful regulatory strategy, strong collaboration, and rigorous attention to participant protections. This role offers meaningful responsibility, opportunities to improve research operations, and the chance to share specialized expertise with colleagues.

Why work for the University?

We have AMAZING benefits and offerexceptional 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

• Bachelor's degree from an accredited institution.
  • 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.
• Three (3) years of clinical research, academic research support, or related experience with at least one (1) year as a subject matter expert and/or team lead.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

• Master's degree in science or health related field.
• Four (4) years clinical research or related experience.
• Experience with University research related platforms.
• Possess a Citi Certification Good Clinical Practice (GCP).

Conditions of Employment

• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

Knowledge, Skills and Abilities

• Strong project management skills and experience within a complex and diverse environment.
• Advanced knowledge and understanding of federal regulations and Citi Certification Good Clinical Practice (GCP).
• Demonstration of strong analytical and problem‑solving skills.
• 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.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Ability to interpret and master complex research protocol information.

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 [e-mail].

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.

Screening of Applications Begins

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by November 16th, 2026. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range

The starting salary range (or hiring range) for this position has been established as $71,517 - $90,970.

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.