Regulatory Coordinator (Open-Rank, Intermediate thru Senior)

University of Colorado•Hybrid, CO

13d•$57,525 - $83,333•Hybrid

About The Position

The Administrative Research Core Regulatory Coordinator is a full-time position in the Department of Obstetrics and Gynecology at the University of Colorado School of Medicine. The position supports 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 specializes in gynecologic oncology studies, including investigator-initiated trials, cooperative group studies such as NRG Oncology, and Phase I–III industry trials. Duties phase in during training, with support from the Regulatory Manager. At the senior level, the Coordinator independently manages regulatory documentation, submissions, and compliance for gynecologic oncology studies throughout the research lifecycle. The role helps ensure ethical and compliant human-subjects research. Work is hybrid, with three days per week on campus and additional in-person attendance as needed for meetings. The position prepares and tracks submissions to regulatory bodies and review committees, maintains audit-ready regulatory records, monitors deadlines, supports quality assurance and compliance, and serves as a liaison among investigators, study teams, sponsors, and university offices. Senior-level duties include developing and maintaining departmental regulatory SOPs, creating educational content, contributing to research communications and best practices, and providing cross-training and coverage. The position is based in a department with a substantial clinical research portfolio. The University offers medical, dental, disability, life and vision insurance; retirement contributions; paid leave; tuition benefits; and reduced-rate public transportation. The role may be eligible for overtime compensation depending on level.

Requirements

Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution; a combination of education and related technical, military, or paraprofessional experience may substitute year for year.
Intermediate level: one year of professional experience coordinating clinical trials, clinical research administration, regulatory affairs, or healthcare compliance.
Senior level: two years of professional experience coordinating clinical trials, clinical research administration, regulatory affairs, or healthcare compliance.
Applicants must meet the applicable minimum qualifications at the time of hire.
Legally authorized to work in the United States without requiring current or future sponsorship.
Proficiency with OnCore, InfoEd, CU Data, Marketplace, and other relevant systems.
Familiarity with FDA regulations, ICH-GCP guidelines, and human research protections.
Excellent knowledge of clinical research regulations and principles of ethical conduct related to human-subjects research.
Ability to communicate effectively in writing and orally.
Ability to work effectively with a diverse population of faculty, staff, and students.
Effective communication and presentation skills, with a demonstrated record of forming collaborative working relationships with physicians and administrative leaders.
Ability to establish and maintain effective working relationships with investigators, study teams, regulatory offices, and sponsors.
Outstanding customer service skills.

Nice To Haves

Three or more years of professional medical, clinical, and/or clinical research coordination experience.
Experience interpreting and applying policies from federal, state, and institutional authorities and serving as a resource for others.
Experience supporting IRB submissions and human-subjects research, particularly in cancer or women’s health research.
Experience maintaining regulatory binders and essential regulatory documentation.

Responsibilities

Prepare, submit, and track complete and accurate gynecologic oncology clinical research applications, amendments, continuing reviews, reportable events, and study closures for applicable review bodies, including COMIRB, WIRB, NCI CIRB/Advarra, and PRMS.
Complete and submit continuing reviews, amendments, and other protocol-specific documents.
Develop informed consent documents, HIPAA authorizations, and participant-facing regulatory documents.
Serve as a regulatory liaison among investigators, industry sponsors, CROs, and University review committees to resolve regulatory, ethical, or institutional approval issues.
Collaborate with investigators, study teams, sponsors, and regulatory offices to facilitate regulatory review and approvals.
Maintain regulatory binders, electronic regulatory files, and databases, including OnCore, ensuring documentation is complete, accurate, and audit-ready.
Lead internal quality assurance audits of study e-files and eReg binders across the gynecologic oncology portfolio and develop CAPA recommendations for the Regulatory Manager.
Monitor study approval periods and regulatory deadlines to support timely submissions and compliance.
Assist the Regulatory Manager with FDA IND/IDE submissions, annual reports, safety reporting, and maintenance, as well as ClinicalTrials.gov registration, maintenance, and results reporting.
Oversee OnCore protocol submissions, regulatory data integrity, and requirements for opening complex oncology studies to accrual.
Review and interpret federal, state, local, and university regulations and guidelines, and advise investigators, fellows, and research staff on regulatory impacts.
Assist the Research Program Director and Regulatory Manager in developing general clinical research policies and procedures.
At the senior level, independently develop and maintain departmental SOPs concerning regulatory policies and procedures.
Participate in cross-training and professional development related to grants and contracts, including budgeting, proposal submissions, and subcontract setup and administration.
Develop content for the Department research edition newsletter and advise research personnel on changing regulations and policies or procedures.
Network with relevant University offices to develop departmental best practices.
Cross-train with team members and provide service coverage when needed.
Identify and participate in training opportunities to enhance knowledge in areas of responsibility.
Develop and present educational content to department research faculty, fellows, and staff at quarterly research meetings, faculty meetings, and other relevant meetings.
Perform other duties as assigned.