Clinical Research Nurse Program Manager

Clinical Research Nurse Program Manager
Description
University of Colorado Anschutz
Department:
Gates Institute
Job Title:
Clinical Research Nurse Program Manager
Position #:

- Requisition #:38789
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).

Hybrid

• 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

• 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.

• 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 environments with the ability to deliver results amid changing priorities.
• Ability to manage and prioritize multiple projects simultaneously across cross-functional teams.
• Demonstrate exceptional attention to detail and strong organizational skills.
• Exercise independent judgment with a high degree of professionalism and accountability.
• Build effective relationships through strong written and verbal communication.
• Proficient in Microsoft Office Suite, with advanced presentation development skills.

February 2, 2026

$68,394 - $86,998.

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The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.