Regulatory and Compliance Coordinator

University of Colorado; United States; Hybrid; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical insurance options

Dental insurance options

Disability and Life Insurance

Retirement 401(a) plan with 10% of pay

PTO and holidays

Tuition benefit

Job summary

University of Colorado Anschutz Medical Campus seeks a Regulatory and Compliance Coordinator to serve as a principal regulatory resource for a diverse portfolio of clinical studies. You will support investigators through feasibility, start-up, oversight, amendments, inspections, and closeout, ensuring participant protection and high-quality regulatory records.

In collaboration with the Clinical Trial Medical Director and PI teams, you will mentor staff, strengthen SOPs, and drive process

Qualifications

• Bachelor's degree required.
• Three years of clinical research or related experience with at least one year as SME/lead.
• Experience coordinating regulatory activities across the trial lifecycle is preferred.

Responsibilities

• Prepare and manage IRB submissions (initial, continuing, amendments, events, closures).
• Coordinate FDA regulatory documentation and submissions; ensure compliance with ICH-GCP and sponsor requirements.
• Maintain inspection-ready regulatory binders and site files with credentials and training disclosures.
• Lead regulatory start-up and closeout activities; support visits, audits, and sponsor monitoring.

Skills

Regulatory coordination

Project management

Communication

Analytical thinking

Education

Bachelor's degree

Master's degree (preferred)

Tools

GCP knowledge

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 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:

• 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 relationship