Regulatory Manager

Job Summary:

The Regulatory Manager will collaborate with the CCTO Regulatory and Compliance Program Director to ensure efficiency and compliance within the program. The Regulatory Manager will be assigned primary areas of focus including 2 or more of the following:

* Regulatory projects associated with Trial Activation

* Regulatory projects associated with Electronic Systems

* Regulatory projects associated with Amendments

* Regulatory projects associated with Federally Funded Studies

* Regulatory aspects of Sponsor Affairs

* Study Maintenance

The Regulatory Manager collaborate with the CCTO Regulatory and Compliance Program Manager and Clinical Research Managers in establishing best practice recommendations for compliance, establishing quality assurance program(s) and implementing standard operating procedures to ensure high quality study conduct

Examples of Work Performed

50% Leadership, Compliance, and Process Improvement

* Provide oversight, direction and leadership for all regulatory operations within the CCTO

* Evaluate and operationalize Regulatory impact for integrating CCTO guidance documents/Cancer Center SOPs into regulatory workflow to bolster compliance and meet Cancer Center strategic goals

* Lead evaluation of regulatory compliance with new sponsor, NCI, and/or FDA initiatives that include rolling out updates to document templates, guidance documents or SOPs as needed

* Lead the implementation of new regulatory technologies such as Advarra eReg, UCHealth RECRUIT

* Assess Regulatory impact of updates to the Biosafety application requirements and direct changes, as needed

* Negotiate standard consent form language with preferred pharmaceutical company partners

* Collaborate with the CCTO/COE Liaison to direct process improvements for non-English speaking research subjects and to ensure adherence to SOPs and applicable guidelines

* Direct revisions to the CIRB Signatory Worksheet (boilerplate language) in collaboration with the Regulatory and Compliance Program Director.

* Engage with other Cancer Center research teams to streamline processes across the Cancer Center with the goal of reducing inconsistencies

* Partner with Regulatory and Compliance Program Director to coordinate RAC team meetings, team trainings, and team building activities or delegates responsibility to team members as appropriate.

* Lead the preparation for external audits and FDA Inspections.

* Lead process to develop, implement and maintain CCTO Guidance documents or 'How To' documents with input from Regulatory Supervisors and CCTO Regulatory Compliance and Quality Program Manager.

* Oversee the development of standard practices for Regulatory department based on FDA Regulations and GCP guidelines and oversees implementation of practices.

* Provide input on University of Colorado Cancer Center SOPs by participating as a member of the Cancer Center SOP working group.

* Evaluate the Regulatory compliance impact of new Cancer Center and institutional programs and directs process improvements, as needed

* Standardize regulatory education and knowledge across the CCTO to continuously improve study compliance

Work Location:

Hybrid - This is not a remote position. This offer is contingent upon you working full-time, hybrid, on the Anschutz Medical Campus. 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.

Qualifications:

Minimum Qualifications:

Education:

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

* A combination of closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.

Experience:

* A minimum of 5 years of clinical research experience

* A minimum of 5 years of Regulatory experience. This can be included in the 5 years of experience above

* A minimum of 2 years of personnel management experience. This can be included in the 5 years of experience above.

Conditions of Employment:

Certification & Licensure Required: Current Biomedical, HIPAA and GCP training (must have within 30 days of hire); current Clinical Research Certification (CCRC, CCRA, CCRP) OR eligible and willing to sit for next exam; must have certification within one year of employment. Failure to complete the certification requirement within one year may be cause for termination.

Preferred Quals:

* Oncology regulatory experience

* Experience with using Advarra OnCore for regulatory tasks (for example, enttering IRB approvals, uploading approved documents, re-consent required functionality)

* Experience working simultaneously with various sponsors and studies in multiple phases

* Experience working in an academic medical setting

* Experience teaching, precepting, and mentoring employees to regulatory and clinical research.

* Experience managing a remote team or working in a remote/hybrid environment

Knowledge, Skills, and Abilities

* Excellent interpersonal communication, organizational skills, and ability to problem-solve and multi-task.

* Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

* Outstanding customer service skills.

* Understands the phases and concepts of clinical trials and the overall philosophies of conducting National Clinical Trials Network (NCTN) research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.

* Knowledge of research study budgets.

* Understanding of computer systems (specifically MS Office Suite, Adobe and Advarra OnCore) and ability to work efficiently within various applications. Examples of work include working within Advarra OnCore, and Advarra eReg to perform regulatory tasks and/or develop guidelines for use of computer systems.

* Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials.

* Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology.

Applicants must meet minimum qualifications at the time of application.

Please be advised that this position is not eligible now or in the future for visa sponsorship.

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: Jamie Gray, Jamie.gray@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by February 23, 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 $74,994 - $95,39. Salary offer will be offered dependent on education and relevant experience.

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.