Clinical Research and Regulatory Affairs Specialist

University of Colorado•Colorado Springs, CO

4d•$71,517 - $95,833•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in a Science field, Behavioral Science, Health, Public Health, Nursing, or other related discipline at an accredited institution.
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.
Must be willing and able to successfully complete Human Subjects Protection and Good Clinical Practice (GCP) training (e.g., CITI) at time of hire.

Nice To Haves

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).

Responsibilities

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.
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.
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.