Clinical Research and Regulatory Affairs Specialist

Job Summary:

The Gates Institute at the University of Colorado Anschutz seeks a highly motivated, detail-oriented Clinical Research and Regulatory Affairs Specialist to support the product and clinical safety lifecycle starting at the preclinical development stage through first-in-human (FIH) Phase I clinical trials through safety monitoring & risk assessment, regulatory compliance & documentation, data integrity & quality control, and process optimization.

This role will act as a subject matter expert for Gates and provide expertise on CAR-T Cell Therapy & CGT Research, pharmacovigilance & risk management, regulatory compliance & clinical trial operations, data analytics & quality control. This role will require a strong background in CAR-T cell biology, as well as clinical research and an understanding of regulatory requirements related to cell and gene therapy (CGT). This position will work directly with the Gates Institute team and the Principal Investigators and closely coordinate with institutional partners, including the clinical research staff, manufacturing facilities, bench researchers, etc.

Key Responsibilities:

Regulatory Operations:

• Coordinate regulatory activities supporting investigator-initiated cell and gene therapy (CGT) programs from preclinical development through first-in-human (FIH) Phase I clinical trials, including preparation and submission of IND applications, protocol amendments, annual reports, and other regulatory documentation.

• Partner with cross-functional teams-including Regulatory Affairs, Clinical Operations, Manufacturing, Quality Assurance, and Principal Investigators-to ensure regulatory deliverables, study activation, and clinical milestones are achieved in compliance with FDA regulations, FACT and ICH Good Clinical Practice (GCP).

• Maintain regulatory documentation and quality control processes to ensure inspection readiness, regulatory compliance, and efficient management of the IND lifecycle.

Surveillance:

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

• Support safety assessments of investigational products under medical monitor oversight, per FDA regulations and internal standards.

• Compile and summarize findings from nonclinical laboratory studies to support evaluation of the safety and activity of investigational CAR-T therapies before first-in-human (FIH) clinical trials.

Clinical Operations:

• Contribute to the preparation of safety reports and other documents for submissions to regulatory agencies.

• 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.

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

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 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.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in a Science field, Behavioral Science, Health, Public Health, Nursing, or other related discipline at an accredited institution.

  • 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.

• 3 years of experience in clinical research or cell and gene therapy research (translational or clinical research).

Applicants must meet minimum qualifications at the time of hire.

Condition of Employment:

• Must be willing and able to successfully complete Human Subjects Protection and Good Clinical Practice (GCP) training (e.g., CITI) at time of hire.

Preferred Qualifications:

• Advanced degree (MSN, PharmD) or the equivalent combination of education, training, and experience from which comparable skills can be acquired, preferably in life sciences or health-related fields.

• Experience with synthesizing laboratory and animal research data for IND submission.

• Experience with grant and manuscript development and submissions.

• Experience with developing and maintaining medical writing QC systems.

• Protocol management.

• Regulatory certification (e.g., RAPS Regulatory Affairs Certification, RAC) or clinical research certification (e.g., SOCRA CCRP, ACRP CCRC).

Competencies/Knowledge, Skills, and Abilities:

• Strong analytical and excellent communication skills.

• Knowledge of pharmacovigilance regulatory requirements.

• Ability to translate preclinical in vitro and in vivo proof-of-concept, pharmacology, and toxicology studies to establish feasibility and rationale for clinical use of the investigational CGT product and characterize the product's safety profile.

• Ability to work effectively in a fast-paced environment and deal effectively with changing priorities.

• Ability to work on multiple projects and with numerous project teams simultaneously.

• Able to interpret clinical and non-clinical data as needed to prepare grants and manuscripts.

• Exceptional attention to detail.

• Effective collaboration and facilitation skills.

• Self-motivated, willing to act with a demonstrated ability to establish relationships.

• Independent judgment, strong organization and communication skills, and a superior customer service focus.

• Strong interpersonal skills (written and verbal) and a high degree of professionalism.

• Ability to prioritize and manage multiple projects and tasks.

• Proficiency in Microsoft Office Suite, electronic regulatory and TMF systems, and safety databases.

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 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:

Immediately and continues until position is filled. For best consideration, apply by September 9, 2026.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as $71,517 - $95,833.

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: http://www.cu.edu/node/153125

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 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.