Hybrid Regulatory & Compliance Lead — Clinical Research

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

Benefits offered by this job

Medical plans

Dental plans

Disability insurance

Life insurance

Vision insurance

401(a) retirement plan

Paid time off: 22 vacation days/year

Sick days: 15/year

Holidays: 15/year

Tuition benefit

ECO Pass

Job summary

University of Colorado Anschutz Medical Campus seeks a Regulatory and Compliance Coordinator for the Division of Cardiology. The role supports a portfolio of clinical studies from feasibility through closeout, ensuring regulatory compliance and participant protection.

Working with investigators, IRBs, sponsors, and partners, you will lead regulatory coordination, SOP improvements, and staff mentorship while promoting compliant study execution across the lifecycle.

Qualifications

• Bachelor's degree required; substitution possible with related experience.
• Three years of clinical or academic research experience, with at least one year as a SME or team lead.

Responsibilities

• Prepare and manage IRB submissions and continuing reviews.
• Coordinate FDA-related regulatory documents and ensure ICH-GCP compliance.
• Maintain inspection-ready regulatory binders and site files.
• Lead start-up and closeout activities; support sponsor monitoring and audits.
• Collaborate with investigators on protocol, consent forms, and regulatory docs.
• Develop SOPs, tools, workflows, and training materials; mentor team.
• Monitor trial workload and provide operational oversight when needed.

Skills

Regulatory knowledge

Project management

Written & verbal communication

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree

Master's degree

Tools

GCP Certification

Job description

University of Colorado Anschutz Medical Campus seeks a Regulatory and Compliance Coordinator for the Division of Cardiology. The role supports a portfolio of clinical studies from feasibility through closeout, ensuring regulatory compliance and participant protection.

Working with investigators, IRBs, sponsors, and partners, you will lead regulatory coordination, SOP improvements, and staff mentorship while promoting compliant study execution across the lifecycle.