Entry-Level Regulatory Compliance Coordinator - Clinical Trials

CU Denver; Aurora (CO); Hybrid; USD 53,000 - 67,000; Full time

Job summary

University of Colorado Anschutz Medical Campus's Cancer Center is seeking an entry-level Regulatory Compliance Coordinator to support FDA/GCP compliant trials, including NCTN and ETCTN. The role emphasizes detail-oriented regulatory tasks and collaboration with the Regulatory Affairs team.

You will prepare and submit regulatory documents, coordinate monitoring visits, manage documents in Advarra OnCore and eReg, and assist with investigator onboarding while supporting study oversight.

Qualifications

• Bachelor's degree in any field required.
• Advanced degree may substitute for experience on a year-for-year basis.
• Experience with regulatory requirements in clinical research preferred.

Responsibilities

• Prepare and submit regulatory documents and ensure regulatory compliance.
• Coordinate regulatory monitoring visits and audits.
• Maintain study and personnel information in regulatory systems.
• Assist with investigator onboarding and site communications.
• Support archiving and regulatory study oversight activities.

Skills

Analytical skills

Attention to detail

Complex problem solving

Communication skills

Interpersonal skills

Customer service

Adaptability

Planning and organizing

Technical skills

Education

Bachelor's degree

Tools

DocuSign

Advarra eReg

OneDrive

eBinders

Job description

University of Colorado Anschutz Medical Campus's Cancer Center is seeking an entry-level Regulatory Compliance Coordinator to support FDA/GCP compliant trials, including NCTN and ETCTN. The role emphasizes detail-oriented regulatory tasks and collaboration with the Regulatory Affairs team.

You will prepare and submit regulatory documents, coordinate monitoring visits, manage documents in Advarra OnCore and eReg, and assist with investigator onboarding while supporting study oversight.