Hybrid Regulatory Lead for Cardiology Clinical Research

University of Colorado; Aurora (CO); Hybrid; USD 72,000 - 91,000; Full time

Job summary

University of Colorado Anschutz Medical Campus seeks a Regulatory and Compliance Coordinator to serve as a principal regulatory resource across clinical studies. You will support investigators from feasibility to closeout, maintain regulatory records, mentor staff, and drive process improvements.

In this role, you will manage IRB and FDA documentation, ensure ICH-GCP compliance, and collaborate with researchers and sponsors to ensure timely, compliant study execution, with a hybrid on-campus

Qualifications

• Bachelor's degree from an accredited institution.
• 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.
• 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).

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

Strong project management

Regulatory knowledge (ICH-GCP)

Analytical and problem-solving skills

Communication skills

Relationship building

Medical terminology

Protocol interpretation

Education

Bachelor's degree

Master’s degree in science or health-related field

Citi Certification Good Clinical Practice (GCP)

Job description

University of Colorado Anschutz Medical Campus seeks a Regulatory and Compliance Coordinator to serve as a principal regulatory resource across clinical studies. You will support investigators from feasibility to closeout, maintain regulatory records, mentor staff, and drive process improvements.

In this role, you will manage IRB and FDA documentation, ensure ICH-GCP compliance, and collaborate with researchers and sponsors to ensure timely, compliant study execution, with a hybrid on-campus