Clinical Trials Regulatory Affairs Coordinator — Hybrid

University of Colorado; United States; Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Excellent benefits

Job summary

The University of Colorado Anschutz Medical Campus, Cancer Center and its Regulatory Affairs team, seeks a Regulatory Affairs Coordinator (Open Rank) to manage regulatory submissions for Phase I–IV trials and ensure compliance with FDA/GCP guidelines. The hybrid role coordinates with multiple review boards and sponsors, delivering timely regulatory documentation.

Ideal candidates will be detail-oriented with strong organizational and communication skills to serve as the central communications

Qualifications

• Drafts or revises informed consent and HIPAA documents.
• Prepares, submits, and tracks regulatory applications and amendments.
• Detail-oriented with strong organizational and communication skills.

Responsibilities

• Serves as regulatory contact person for ongoing clinical studies.
• Provides guidance to clinical teams for Unanticipated Problem (UAP) or Serious Adverse Event (SAE) reporting.
• Works with clinical team to ensure protocols move through our complex process as quickly as possible.
• Drafts or revises informed consent and HIPAA documents.
• Prepares, submits, and tracks regulatory applications, amendments, continuing reviews, consent documents, and other required study documentation.
• Reviews, submits, and files CIOMS, SUSARS, Line-listings, IND and other safety reports as needed.
• Coordinates submissions to applicable regulatory and institutional review bodies and ensures compliance with required timelines and approval requirements.
• Maintains regulatory documentation and study milestones in institutional tracking systems (Advarra OnCore and eRegulatory management system).
• Serves as back up coverage during RAC absences.

Skills

Regulatory affairs

Clinical trials

FDA regulations

GCP

IRB submissions

Documentation

Communication

Tools

Advarra OnCore

eRegulatory management system

PRMS

COMIRB

WCG IRB

CIRB

CTSU

SWOG

NSABP/RTOG/GOG

Job description

The University of Colorado Anschutz Medical Campus, Cancer Center and its Regulatory Affairs team, seeks a Regulatory Affairs Coordinator (Open Rank) to manage regulatory submissions for Phase I–IV trials and ensure compliance with FDA/GCP guidelines. The hybrid role coordinates with multiple review boards and sponsors, delivering timely regulatory documentation.

Ideal candidates will be detail-oriented with strong organizational and communication skills to serve as the central communications