Regulatory Coordinator (Open-Rank, Intermediate thru Senior)

Job Summary:

The Administrative Research Core (ARC) Regulatory Coordinator is a full-time position within the Department of Obstetrics and Gynecology at the University of Colorado School of Medicine. This role supports a diverse portfolio of clinical research studies by managing regulatory processes across the study lifecycle, including preparing and submitting regulatory applications, maintaining essential study documentation, tracking approvals and deadlines, and ensuring compliance with Institutional Review Board (IRB), U.S. Food and Drug Administration (FDA), Good Clinical Practice (GCP), and university requirements. The Coordinator will specialize in gynecologic oncology studies and manage regulatory documentation and submissions related to clinical research protocols including investigator-initiated trials (IITs), cooperative group studies (e.g., NRG Oncology), and Phase I–III industry trials. As an integral member of the Administrative Research Core, this position helps ensure the ethical and compliant conduct of human subjects research while providing an excellent opportunity for professional growth in clinical research regulatory affairs. Duties listed will phase in as this position is trained, receiving support from the Regulatory Manager.

At the senior level, the Coordinator will independently manage regulatory documentation, submissions, and compliance for gynecologic oncology studies throughout the research lifecycle, ensuring adherence to IRB, FDA, GCP, and university requirements while supporting the ethical conduct of human subjects research.

Key Responsibilities:

Regulatory Oversight: 70%

• Prepares, submits, and tracks complete and accurate Gyn Onc clinical regulatory applications, amendments, continuing reviews, reportable events, and study closures to all required regulatory bodies for the conduct of clinical research at the University of Colorado. This may include, but is not limited to, the following:

  • Colorado Multiple Institutional Review Board (COMIRB)

  • Western Institutional Review Board (WIRB)

  • NCI Central Institutional Review Board (CIRB/Advarra)

  • Protocol Review and Monitoring System (PRMS)

  • Completes and submits continuing reviews, amendments, and other protocol-specific documents.

• Develops clear and accurate informed consent documents, HIPAA authorizations, and participant-facing regulatory documents.

• Serves as a regulatory liaison interfacing between Gyn Onc/OB-GYN investigators, industry sponsors, CROs, and University review committees to resolve complex regulatory, ethical, or institutional approval bottlenecks.

• Collaborates with investigators, study teams, sponsors, and regulatory offices to facilitate efficient regulatory review and approval processes.

Quality Assurance: 25%

• Maintains regulatory binders and electronic regulatory files and databases including OnCore to ensure complete, accurate, and audit-ready documentation.

• Leads internal quality assurance audits of shared study e-files and eReg binders across the Gyn Onc portfolio, developing corrective and preventive action (CAPA) recommendations for the Regulatory Manager.

• Monitors study approval periods and regulatory deadlines to ensure timely submissions and compliance.

• Assists the Regulatory Manager with FDA (IND/IDE) submissions, annual reports, safety reporting, and maintenance, as well as full ClinicalTrials.gov protocol registration, maintenance, and results reporting.

• Oversees and maintains OnCore protocol submissions, regulatory data integrity, and requirements for opening complex oncology studies to accrual.

• Reviews and interprets federal, state, local, and university regulations and guidelines, proactively advising Gyn Onc investigators, fellows, and research staff on regulatory impacts.

Other Duties: 5%

• Assists the Research Program Director and Regulatory Manager with developing general research policies and procedures relating to clinical research.

Senior Level:

• Independently responsible for development and maintenance of department SOPs relating to regulatory policies and procedures.

• Participates in cross-training and professional development opportunities related to grants and contracts to enhance skills and knowledge in this area including budgeting, proposal submissions, and subcontract setup and administration.

• Develops original content for Department research edition newsletter, including advising research personnel on changing regulations and policies/procedures.

• Networks with relevant University offices to build up the Department’s Best Practices.

• Cross trains with the other members of the team and provides service coverage when needed. 

• Identifies and participates in training opportunities to enhance knowledge in all areas of responsibilities.

• Develops and presents original educational content to Department research faculty, fellows, and staff at quarterly research meetings, faculty meetings, and other relevant meetings as necessary.

• Perform other duties as assigned.

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 Department of Obstetrics and Gynecology at the University of Colorado is a world-class research enterprise, ranked 25th in the nation by the Blue Ridge Institute for federal funding. The Department currently has over 130 active clinical an impressive research portfolio of $25M in existing federal and foundation grants and contracts through the lifetime of the projects, increasing in budget annually by $12M. Departmental faculty provide a full-spectrum of clinical care for women of all ages, participate in research, and provide education to students and residents.

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:

<