University of Colorado Anschutz Medical Campus

Department: Medicine – Division of Hematology

Job Title: Regulatory Affairs Coordinator (RAC) (Open Rank, Entry to Senior)

Position #:00842522 – Requisition #:38354

Job Summary:

The University of Colorado Division of Hematology, Clinical Trials Unit is seeking a Regulatory Affairs Coordinator. This position is responsible for providing regulatory support for clinical trials and investigator-initiated studies for the Division of Hematology.

The Regulatory Affairs Coordinator (RAC) will work closely with the HCTU Leadership Team, Principal Investigators, Industry Sponsor/CRO Representatives, IRBs, and other departments on campus to provide support for the Division’s clinical trial portfolio. This position will provide support for studies that may involve industry-sponsored Phase I, II, III, and IV clinical trials and investigator-initiated studies. The RAC will ensure the accurate progress of clinical research from the planning and approval stages through study completion and post-study closure.

Key Responsibilities:

• Serves as regulatory contact person for ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.

• Submits complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research at the University of Colorado. This may include, but is not limited to, the following:

  • Colorado Multiple Institutional Review Board (COMIRB)

  • Protocol Review and Monitoring System (PRMS)

  • Hospital Research Support Services (UCH-RSS)

  • University of Colorado Hospital Biosafety Committee (IBC)

  • University of Colorado Hospital Clinical Trials Research Center (CTRC)

• Writes clear and accurate subject informed consent documents and HIPAA (Health Insurance Portability and Accountability Act) Authorizations.

• Completes and submits continuing reviews, amendments, and safety updates as needed.

• Participates in Data Safety Monitoring Committee (DSMC) internal audits.

Updates database with regulatory submission and approval dates.

Work Location:

Hybrid – this role is eligible for a hybrid schedule of two (2) days per week on campus and as needed for in-person meetings.

Why Join Us:

Investigators in the Division of Hematology’s Blood Cancer Program are actively engaged in multiple research activities aimed at improving outcomes for patients with blood cancers and related disorders. These studies are wide-ranging and involve extensive collaboration between laboratory scientists and physicians. Our work is funded by the National Cancer Institute (NCI), the American Cancer Society (ACS), the Leukemia and Lymphoma Society (LLS), and numerous other foundations and industry sources.

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