Regulatory Compliance Coordinator (Entry Level)
University of Colorado
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Job summary
University of Colorado Anschutz Medical Campus is seeking an Entry Level Regulatory Compliance Coordinator to support FDA, GCP, and institutional regulatory requirements for cancer clinical trials. The role involves preparing regulatory documents, coordinating audits, and maintaining trial documentation in systems like Advarra OnCore and eReg.
This hybrid position emphasizes strong organization, communication, and collaboration with the Regulatory Affairs team to ensure compliance across Phase
Qualifications
- Education: Bachelor's degree in any field from an accredited college or university.
- Substitution: A combination of education and related experience may be substituted for the bachelor’s degree on a year-for-year basis.
- An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
Responsibilities
- Clinical Trial Compliance, Monitoring, and Auditing - Develops and maintains knowledge of GCP, FDA rules and regulations.
- Assists with preparation of regulatory documents to support accuracy and compliance with regulations.
- Oversees essential document completion through DocuSign and 21 CFR Part 11.
- Collaborates with Regulatory Affairs Coordinators to support audits and FDA inspections.
- Coordinates regulatory monitoring visits for the assigned workload.
Skills
Education
Tools
Job description
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.
- 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.
- 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.
Hybrid – this role is eligible for a hybrid schedule of #3 days per week on campus and as needed for in-person meetings.
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 research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world‑class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.
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: 10/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.
To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness
Education: 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 be substituted for the bachelor’s degree on a year-for-year basis.
An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
The individual must obtain and track continuing education regardless of whether the individual holds an additional certification:
- Regulatory Compliance Coordinator - 5 continuing education units per calendar year
Applicants must meet minimum qualifications at the time of application.
- 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.
- 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
- This position is required to work a hybrid schedule (on-campus, 3 days per week).
- Analytical Skills - Ability to interpret and master complex research protocol information.
- Attention to Detail – Excellent attention to detail and ability to interpret and master complex research protocol information
- Complex Problem Solving – Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
- Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal.
- Interpersonal Skills – Ability to establish and maintain effective working relationships with employees at all level; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality.
- Customer Service – Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems.
- Adaptability – Adapts quickly to change and is able to manage multiple priorities and deadlines in a calm, organized manner; is open to new ideas and methods; is able to work independently and as part of a team.
- Planning and Organizing – Sets priorities, anticipates obstacles when planning ahead, manages time effectively to accomplish tasks.
- Technical Skills – Adept at utilizing technology to effectively communicate and complete work (e.g. MS Outlook, MS Word, MS Excel); ability to learn new technology.
The starting salary range (or hiring range) for this position has been established as HIRING RANGE (minimum – 40th posting max).
Entry: $52,860 - $67,239
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: http://www.cu.edu/node/153125
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.
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.
The University of Colorado Anschutz Medical Campus 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.
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.
Research Services
U0001 -- Anschutz Med Campus or Denver
Full-time
Oct 30, 2026
Ongoing
Christina Marvel
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