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:

Intermediate Level:

• A 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.

  • Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.

• One (1) year of professional experience coordinating clinical trials, clinical research administration, regulatory affairs, or healthcare compliance.

Senior Level:

• A 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.

  • Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.

• Two (2) years of professional experience coordinating clinical trials, clinical research administration, regulatory affairs, or healthcare compliance.

Applicants for all levels must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Three or more years of professional medical, clinical and/or experience coordinating clinical research.

• Experience interpreting and applying policies from multiple levels of authority (federal, state, and institutional) and serving as a resource for others.

• Experience supporting IRB submissions and human subjects' research specifically for cancer research or women’s health research.

• Experience maintaining regulatory binders and essential regulatory documentation.

Conditions of Employment:

• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

Knowledge, Skills and Abilities:

• Proficiency with Oncore, InfoEd, CU Data, Marketplace, and other relevant systems.

• Familiarity with FDA regulations, ICH-GCP guidelines, and human research protections.

• Demonstrated ability to work effectively with a diverse population of faculty, staff and students.

• Excellent knowledge regarding clinical research regulations and principals of ethical conduct.

• Ability to communicate effectively, both in writing and orally.

• Demonstrated ability to work effectively with a diverse population of faculty, staff and students.

• Effective communication/presentation skills and a proven track record of forming collaborative and effective working relationships with physicians and administrative leaders.

• Excellent knowledge regarding clinical research regulations and principles of ethical conduct related to human subjects research.

• Understanding of Good Clinical Practice (GCP) guidelines and regulatory compliance requirements.

• Ability to establish and maintain effective working relationships with investigators, study teams, regulatory offices, and sponsors.

• Outstanding customer service skills.

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position

2. Curriculum vitae / Resume

3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Naila Naushad, naila.naushad@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues until position is filled. For best consideration, apply by November 30, 2026.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established at:

• Intermediate Level: $57,525 - $77,083

• Senior Level: $62,189 - $83,333

The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu​.

Background Check Statement:

The University of Colorado Anschutz is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.