Regulatory Affairs Coordinator

Position: Regulatory Affairs Coordinator (Open Rank)

• Colorado Multiple Institutional Review Board (COMIRB)

University of Colorado Anschutz Medical Campus Department:
Cancer Center – Cancer Clinical Trials Office (Regulatory Team)

Working Title:

Regulatory Affairs Coordinator (Open Rank)
Position #:  

– Requisition #: 41584

Job Summary:

As an important member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position works with Phase I-IV industry sponsored (Pharmaceutical), Cooperative Group (NCTN) and/ or Investigator initiated clinical trials in accordance with FDA Regulations, Good Clinical Practice (GCP) and applicable guidelines or policies. The successful candidate will be responsible for providing regulatory management and oversight for clinical trials, including drafting informed consent documents;

preparing and submitting all study‑related regulatory documents (Form 1572, Financial Disclosure forms, continuing review, amendments) to applicable review committees (PRMS, IRB of record, UCHealth Research Administration); and supporting clinical teams with the development and submission of Unanticipated Problems.

In order to succeed in this position, the individual must be detail-oriented and able to demonstrate superior organizational skills in order to successfully track multiple tasks occurring in parallel. This incumbent must be self‑motivated to complete tasks quickly and within set deadlines. This position is the ‘hub’ of communication between and internal stakeholders so superior oral and written communication skills are required.

Key Responsibilities for All Levels

• Serves as regulatory contact person for ongoing clinical research studies
• Provides guidance to clinical teams for Unanticipated Problem (UAP) or Serious Adverse Event (SAE) reporting
• Works with clinical team to ensure protocols are moving 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. This may include, but not limited to:
  • Colorado Multiple Institutional Review Board (COMIRB)
  • Western Copernicus Group Institutional Review Board (WCG IRB)
  • NCI Central Institutional Review Board (CIRB)
  • Protocol Review and Monitoring System (PRMS)
• Navigates applicable NCTN websites:
  • Clinical Trials Support Unit (CTSU)
  • Southwest Oncology Group (SWOG)
  • NRG Oncology (NSABP, RTOG, GOG)
• Maintains regulatory documentation and study milestones in institutional tracking systems (Advarra OnCore and eRegulatory management system)
• Serves as back up coverage during RAC absences

Additional Duties For RAC II

• Assists in the completion of initial Institutional Biosafety (IBC) applications
• Assists in the completion of Single‑Patient IND (sIND) processes and Expanded Access Programs
• Provides shadowing of daily tasks for new members of the Regulatory Affairs team

Additional Duties For RAC III

• Completes all required documentation for submissions specific to trials requiring Institutional Biosafety Committee (IBC) oversight
• Completes all required documentation for Single‑Patient IND (sIND) processes and Expanded Access Programs
• Assists with training for new members of the Regulatory Affairs team
• Potentially meets with representatives from Food and Drug Administration (FDA) for review of records

Work Location:

Hybrid – this role is eligible for a hybrid schedule of #3 days per week on campus and as needed for in‑person meetings.

Why Join Us:

The University of Colorado…