Regulatory & Compliance Lead, Clinical Research (Hybrid)

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

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.