University of Colorado Anschutz

Department: Gates Institute

Job Title: Clinical Research Nurse Program Manager

Position #:00817939 – Requisition #:38789

Job Summary:

The Gates Institute at the University of Colorado Anschutz Medical Campus is seeking a highly motivated, detail-oriented Clinical Research Nurse Program Manager to support the full product and clinical safety lifecycle of cell and gene therapy (CGT) programs—from preclinical development through first-in-human (FIH) Phase I clinical trials. This role serves as a subject matter expert and supports clinical trial operations, clinical and safety monitoring, regulatory compliance, policy development, medical and scientific writing, data integrity, quality control, and process optimization. The position partners closely with Principal Investigators, Gates Institute leadership, and institutional collaborators—including clinical research teams, manufacturing facilities, and translational researchers—to ensure compliant, high-quality execution of early-phase clinical programs.

Clinical Research Nurses in this role support patient-oriented research involving human subjects, including studies focused on mechanisms of disease, therapeutic interventions, early-phase clinical trials, and the development of novel technologies. Responsibilities may also include contributing to outcomes research, health services research, and select epidemiologic or behavioral studies, while ensuring adherence to institutional, federal, and international research policies, regulatory requirements, and ethical standards.

Key Responsibilities:

• Manages the day-to-day operations and compliance of multiple highly complex Phase I clinical trials and studies across internal and external teams.

• Monitor and review adverse event reports and other safety data from clinical trials and other sources.

• Use expertise to conduct thorough safety assessments of investigational products per FDA regulations and internal standards.

• Perform accurate coding of Adverse Events (AEs) for both serious and non-serious events using medical terminology via MedDRA (Medical Dictionary for Regulatory Activities).

• Process, track, and coordinate adjudication of serious adverse event (SAE) reports and determine appropriate follow-up activities.

• Ensure timely processing and submission of expedited IND Safety Reports to the Sponsor Authorized Representative.

• Use expertise to implement quality control (QC) processes to ensure data integrity, consistency, and compliance with regulatory standards.

• Ensure proper documentation and archiving safety-related data following Good Clinical Practice (GCP) and regulatory guidelines.

• Assist with developing or develop protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs).

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 opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ hig