Regulatory Affairs Supervisor

Job Summary:

This position oversees their regulatory unit in the Cancer Clinical Trials Office (CCTO) and directly supervises their assigned regulatory unit staff. The Regulatory Research Supervisor ensures regulatory compliance for clinical research studies, provides leadership and mentorship to regulatory personnel, and collaborates with investigators, sponsors, and research teams to support the timely and compliant conduct of clinical trials. The position also contributes to quality assurance, process improvement, and operational initiatives while serving as a regulatory subject matter expert within the CCTO.

Key Responsibilities:

50% Supervisory - Training/Mentorship/Workload Management

* Assures adherence within their regulatory unit to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies.

• Arranges orientation and provides training, supervision, and mentorship to their regulatory unit.
• Supervises vacation, out of office coverage, and time management of direct reports.

Makes recommendations regarding regulatory personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions with guidance from Regulatory Manager. This would include letters of expectations being written and delivered to direct reports.

• Monitors workload acuity with guidance from the Regulatory Manager.

* Assists regulatory specialists with technical issues, problem solving and intervention when appropriate. Answers questions from regulatory team including but not limited to processes, guidance documents, sponsor/ monitor questions, approval committee queries, and department logistics.

* Ensures required timelines are met for submission, approval and distribution of protocol amendments, consent revisions and all applicable protocol specific documents for their regulatory unit.

* Assures compliance with OnCore entries ensuring that accuracy is maintained.

40% Leadership/Compliance/Process Improvement

• As part of the regulatory leadership team, collaborates with other Regulatory Supervisors and Regulatory Managers to identify team challenges, solutions, and improvement ideas.
• Develops a firm understanding of institution/department policies and guidance documents, recommending updates as applicable.
• Collaborates with Clinical Research Managers to ensure protocol amendments are processed in an efficient and timely manner.

* Works closely with Regulatory Manager and CCTO Project Manager(s) to ensure protocol opening timelines and protocol opening policies are met and followed.

* Actively participates in Regulatory team meetings and department meetings. This includes providing agenda items and discussion points.

* Participates in external audits and internal process improvement strategies to promote consistent best practices.

* Performs routine quality assurance audits on electronic regulatory binders within their regulatory unit as needed.

10% Regulatory Affairs Coordination and Coverage

* May serve as regulatory contact and carry a regulatory workload as needed for team coverage and understanding of regulatory tasks and job functions.

• Serves as back-up to staff absences, vacancies, within assigned regulatory unit or across regulatory team as needed.

* Serves as back-up to Regulatory Manager if needed.

Work Location:

Hybrid - This is not a remote position. This offer is contingent upon you working full-time, hybrid, on the Anschutz Medical Campus. You may be eligible to work a hybrid schedule after six months of employment. This benefit must be approved by your supervisor. In the event of departmental workload increase or special projects, you may be asked to report full-time on site until project completion.

Why Join Us:

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.

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: 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

Qualifications:

Minimum Qualifications:

Education: Bachelor's degree with a preferred emphasis in business, health administration, communications, biological or social science, or any other field of study related to the work assignment.

Experience: Three (3) years of clinical research experience, with at least 2 of those 3 years in regulatory affairs.

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.

Applicants must meet minimum qualifications at the time of application.

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.

Preferred Qualifications:

* Two years Oncology research experience

* Experience with IRB, Ethics Committee

* Working knowledge of Advarra OnCore and Advarra eRegulatory platforms

* Experience with Sponsors and Audits

* Advance knowledge of ICH Guidelines, FDA and HIPAA Regulations

* Additional certification (one of the following):

* CCRC - Certified Clinical Research Coordinator

* CCRP - Certified Clinical Research Professional

* CCRA - Certified Clinical Research Associate

Condition of Employment:

Certification required within 1 year of hire (one of the below):

* CCRC - Certified Clinical Research Coordinator

* CCRP - Certified Clinical Research Professional

* CCRA - Certified Clinical Research Associate

Knowledge, Skills and Abilities:

* 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.

* Knowledge of and experience with basic human anatomy, physiology, and medical terminology.

* Intermediate to Advanced Microsoft Office skills (Excel, Word, Outlook).

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: Jatonya Turner: Jatonya.turner@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by June 11, 2026. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as HIRING RANGE) ($71,517 - $90,970).

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

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 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.

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.