Regulatory Compliance Coordinator (Entry Level)

Job Summary:

As a member of the Cancer Clinical Trials Office (CCTO) Regulatory Affairs team, this position provides professional support for Phase I-IV industry-sponsored pharmaceutical trials, National Clinical Trials Network (NCTN) and Experimental Therapeutics Clinical Trials Network (ETCTN) trials, and investigator-initiated clinical trials. The position supports compliance with Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP), and applicable institutional and regulatory requirements.

This entry-level role supports the regulatory management of lower-complexity or lower-acuity studies, including studies in long-term follow-up and industry studies nearing IRB closure. Responsibilities include preparing, reviewing, completing, and submitting regulatory documents; coordinating regulatory monitoring visits and audit activities; maintaining study and personnel information in Advarra OnCore and eReg; supporting investigator onboarding; assisting with NCTN, CTSU, CIRB, and CTEP activities; and coordinating study archiving. Work is performed in collaboration with Regulatory Affairs team members and the Regulatory Affairs Manager.

In order to succeed in this position, the individual must be detail-oriented and able to demonstrate superior organizational skills in order to successfully track multiple tasks occurring in parallel. This incumbent must be self-motivated to complete tasks quickly and within set deadlines. This position is the ‘hub’ of communication between and internal stakeholders so superior oral and written communication skills are required.

Key Responsibilities:

Clinical Trial Compliance, Monitoring, and Auditing - 40%

• Develops and maintains knowledge of Good Clinical Practice, FDA rules and regulations related to clinical trials, National Institutes of Health (NIH) guidelines, International Council for Harmonisation (ICH) guidelines, and Health Insurance Portability and Accountability Act (HIPAA) requirements related to clinical trials.

• Assures adherence to research standards established by the FDA, Office for Human Research Protections (OHRP), UCHealth, NCI, and other applicable regulatory agencies.

• Assists with preparation of regulatory documents to support accuracy and compliance with applicable regulations and institutional policies.

• Oversees essential document completion through DocuSign in accordance with institutional requirements and 21 CFR Part 11.

• Collaborates with Regulatory Affairs Coordinators to support audits and FDA inspections by managing regulatory documents, eBinders, and auditor requests.

• Coordinates regulatory monitoring visits for the assigned workload, including scheduling and confirming visits.

Clinical Trial Documentation, Systems, and Study Oversight - 60%

• Maintains lower-risk studies in long-term follow-up and industry studies nearing IRB closure.

• Assists with new investigator onboarding activities, including completion of documentation and organizing required documentation

• Compiles enrollment information for continuing review submissions.

• Maintains the Doctors by Disease Site spreadsheet as investigators are onboarded or leave the institution.

• Coordinates regulatory study archiving activities to support record retention in accordance with GCP

• Assists with Clinical Trials Support Unit (CTSU) or lead-site communications and new site investigators.

• Maintains knowledge of CIRB and local institutional policies, procedures, and requirements related to Principal Investigator worksheets.

• Provides backup coverage during team member absences.

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 University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "prevent and conquer cancer. Together." At the heart of our mission is the work to “unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education.”

Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered researc