Clinical Research Nurse Program Manager

Overview

University Staff

Organization: University of Colorado Anschutz

Department: Gates Institute

Job Title: Clinical Research Nurse Program Manager

Position #:

Requisition #: 38789

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.

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

Hybrid: The role is eligible for a hybrid schedule of 3 days per week on campus and in-person meetings as needed.

The opportunity offered by the Gates Institute is one of a kind. We blend the best of a large research organization with a family atmosphere of a team of 50+ dedicated people on a top-tier research campus—the University of Colorado Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. We are only limited by our resources and need you to make our journey a success. In addition to the benefits offered, links below identify exciting life sciences the Gates Institute is delivering to patients.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave. The University of Colorado offers an excellent benefits package including:

• Medical:
  Multiple plan options
• Dental:
  Multiple plan options
• Additional Insurance:
  Disability, Life, Vision
• Retirement 401(a) Plan:
  Employer contributes 10% of your gross pay
• Paid Time Off:
  Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 15/year
• Tuition Benefit:
  Employees have access to this benefit on all CU campuses
• ECO Pass:
  Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Minimum Qualifications:

• Bachelor's degree in nursing.
• Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis.
• 4-6 years of professional, relevant clinical research experience in oncology and/or cell and gene therapy.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Two years of experience working in clinical research.
• Two years of experience working in clinical nursing or a related field.
• Experience with synthesizing laboratory data.

• Adaptable in ambiguous, fast-paced…