Clinical Research Nurse Program Manager

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+ highly dedicated people, operating 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, a few links are included below, identifying some of the exciting life sciences the Gates Institute isdelivering 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.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in nursing.

• Substitution: A combination of education and related technical/miliary/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.

Competencies/Knowledge, Skills, and Abilities:

• 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.

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to:

Vanessa McWhirt, vanessa.mcwhirt@cuanschutz.edu

Screening of Applications Begins:

Screening begins on February 2, 2026.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $68,394 - $86,998.

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

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.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.