Regulatory and Compliance Coordinator

University of Colorado•Hybrid, CO

1d•$71,517 - $90,970•Hybrid

About The Position

The Regulatory and Compliance Coordinator serves as a principal-level regulatory resource for a diverse portfolio of clinical research studies in the University of Colorado Anschutz Division of Cardiology. The role supports investigators and research teams throughout the clinical trial lifecycle, from feasibility and study start-up through ongoing oversight, amendments, inspections, and closeout. The position helps protect research participants, maintain high-quality regulatory records, and support timely, compliant study execution. Working closely with the Clinical Trial Medical Director, Clinical Trial Program Manager, principal investigators, institutional review boards, sponsors, and clinical partners, the coordinator leads complex regulatory coordination, strengthens standard operating procedures, mentors team members, and contributes to continuous process improvement. The role is eligible for a hybrid schedule of 3–4 days per week on campus, with in-person attendance as needed for study activities, meetings, and regulatory visits.

Requirements

Bachelor's degree from an accredited institution; a combination of education and related technical, military, or paraprofessional experience may be substituted for a bachelor's degree on a year-for-year basis.
Three years of clinical research, academic research support, or related experience, including at least one year as a subject matter expert and/or team lead.
Strong project management skills and experience within a complex and diverse environment.
Advanced knowledge and understanding of federal regulations and Citi Certification Good Clinical Practice (GCP).
Strong analytical and problem-solving skills.
Ability to communicate effectively in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Knowledge of basic human anatomy, physiology, and medical terminology.
Ability to interpret and master complex research protocol information.
Legal authorization to work in the United States without requiring sponsorship; the position does not provide work visa sponsorship or employment authorization now or in the future.

Nice To Haves

Master's degree in a science or health-related field.
Four years of clinical research or related experience.
Experience with University research-related platforms.
Citi Certification in Good Clinical Practice (GCP).

Responsibilities

Prepare and manage IRB submissions, including initial reviews, continuing reviews, amendments, reportable events, and study closures.
Coordinate FDA-related regulatory documentation and submissions, as applicable, and ensure compliance with ICH-GCP, institutional policies, and sponsor requirements.
Maintain accurate, current, inspection-ready regulatory binders and investigator site files, including investigator credentials, training, and disclosures.
Lead regulatory start-up and closeout activities; coordinate site qualification and initiation visits; and support sponsor monitoring, audits, and inspections.
Partner with investigators and research staff on protocol, consent-form, feasibility, and regulatory documentation needs.
Develop and improve SOPs, tracking tools, workflows, and training materials; provide regulatory guidance and mentorship across the research team.
Collaborate with clinical research leadership to monitor trial workload, coordinate priorities, and provide operational oversight when needed.