Entry-Level Regulatory Trials Coordinator – Hybrid

University of Colorado; United States; Hybrid; USD 52,000 - 76,000; Full time

Job summary

University of Colorado Anschutz Medical Campus is seeking an entry-level Regulatory Compliance Coordinator to support FDA/GCP compliance for Phase I–IV trials within the Cancer Clinical Trials Office (CCTO). The role collaborates across the Regulatory Affairs team to ensure regulatory documents are accurate and timely.

Hybrid work arrangement with on-campus and remote activities. You will assist with investigator onboarding, site visits, and regulatory archiving, contributing to the site's

Qualifications

• Familiarity with FDA regulations, GCP, and privacy rules (HIPAA) for clinical trials.
• Experience supporting regulatory submissions, file maintenance, and study documentation.
• Ability to coordinate audits/inspections and maintain regulatory binders.

Responsibilities

• Prepare and submit regulatory documents for trials.
• Coordinate regulatory monitoring visits and audit activities.
• Maintain study and personnel data in OnCore and eReg; support investigator onboarding.

Skills

FDA regulations

GCP

HIPAA

OnCore

eReg

DocuSign

Audit support

Regulatory coordination

Tools

Advarra OnCore

eReg system

Job description

University of Colorado Anschutz Medical Campus is seeking an entry-level Regulatory Compliance Coordinator to support FDA/GCP compliance for Phase I–IV trials within the Cancer Clinical Trials Office (CCTO). The role collaborates across the Regulatory Affairs team to ensure regulatory documents are accurate and timely.

Hybrid work arrangement with on-campus and remote activities. You will assist with investigator onboarding, site visits, and regulatory archiving, contributing to the site's