Regulatory Compliance Coordinator (Entry Level)
About The Position
As a member of the Cancer Clinical Trials Office Regulatory Affairs team, the Regulatory Compliance Coordinator 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 FDA regulations, Good Clinical Practice (GCP), and applicable institutional and regulatory requirements. This entry-level role supports regulatory management of lower-complexity or lower-acuity studies, including studies in long-term follow-up and industry studies nearing IRB closure. Work includes 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. The coordinator collaborates with Regulatory Affairs team members and the Regulatory Affairs Manager. The role requires strong organization, attention to detail, initiative, timely task completion, and excellent written and oral communication. The position follows a hybrid schedule, with three days per week on campus and additional in-person attendance as needed for meetings. Applicants must be legally authorized to work in the United States without sponsorship. The coordinator must obtain and track five continuing education units per calendar year.
Requirements
- Bachelor’s degree in any field from an accredited college or university; a combination of education and related technical, military, paraprofessional, or professional experience may substitute year for year.
- Obtain and track five continuing education units per calendar year.
- Must be legally authorized to work in the United States without requiring current or future sponsorship.
- Must work a hybrid schedule, including three days per week on campus.
- Demonstrated ability to interpret complex research protocol information, maintain attention to detail, solve problems, communicate effectively in writing and verbally, and maintain confidentiality.
- Ability to establish and maintain effective working relationships, provide excellent customer service, adapt to change, manage multiple priorities and deadlines, plan and organize work, and work independently and as part of a team.
- Ability to use technology to communicate and complete work, including MS Outlook, Word, and Excel, and to learn new technology.
Nice To Haves
- One year of professional medical, clinical, and/or research experience.
- Experience with human-subject or clinical research regulations.
- Basic knowledge of ICH/GCP guidelines, FDA regulations, and HIPAA requirements governing clinical research.
- Experience working in an academic and/or medical environment.
- Experience using a clinical trial management system, Advarra eReg, DocuSign, and OneDrive.
- A directly related master’s or doctoral degree may substitute for experience year for year.
Responsibilities
- Develop and maintain knowledge of GCP, FDA clinical-trial rules and regulations, NIH and ICH guidelines, and HIPAA requirements related to clinical trials.
- Support adherence to research standards established by the FDA, OHRP, UCHealth, NCI, and other applicable regulatory agencies.
- Assist with preparing regulatory documents to ensure accuracy and compliance with regulations and institutional policies.
- Oversee completion of essential documents through DocuSign in accordance with institutional requirements and 21 CFR Part 11.
- Collaborate with Regulatory Affairs Coordinators to support audits and FDA inspections by managing regulatory documents, eBinders, and auditor requests.
- Coordinate regulatory monitoring visits for assigned studies, including scheduling and confirming visits.
- Maintain lower-risk studies in long-term follow-up and industry studies nearing IRB closure.
- Assist with new investigator onboarding, including completing and organizing required documentation.
- Compile enrollment information for continuing review submissions.
- Maintain the Doctors by Disease Site spreadsheet as investigators join or leave the institution.
- Coordinate regulatory study archiving to support record retention in accordance with GCP.
- Assist with CTSU or lead-site communications and new site investigators.
- Maintain knowledge of CIRB and local institutional policies, procedures, and requirements related to Principal Investigator worksheets.
- Provide backup coverage during team member absences.
Benefits
- Medical insurance with multiple plan options.
- Dental insurance with multiple plan options.
- Disability insurance.
- Life insurance.
- Vision insurance.
- Employer contribution of 10% of gross pay to the 401(a) retirement plan.
- Paid time off accruals.
- 22 vacation days per year, with a maximum accrual of 352 hours.
- 15 sick days per year, with unlimited maximum accrual.
- 10 holiday days per year.
- Tuition benefit available on all CU campuses.
- Reduced-rate ECO Pass for RTD bus and light rail service.
- Additional perks and programs through CU Advantage.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
