Regulatory and Compliance Program Director

Job Summary:

The Regulatory and Compliance Program Director is a senior member of the clinical research management team in the implementation of clinical research trials in the Cancer Clinical Trials Office (CCTO) of the Cancer Center at the University of Colorado, and oversees the Regulatory Affairs and Quality and Compliance teams This position collaborates with the Clinical Research Program Director and the Trial Activation and Clinical Finance Program Director on oversight of CCTO process, initiatives, compliance, and departmental needs. Position provides direction and oversight to a team of regulatory and compliance education staff. This position is responsible for creating overall team objectives to meet the Cancer Center's overall strategic goals and manages workload balance across multiple teams. This position will be responsible for forecasting program staffing needs, developing and implementing comprehensive guidelines, policies and best practices within the scope of assigned responsibilities. The Regulatory and Compliance Program Director collaborates with the CU Cancer Center Quality and Compliance Program Director in establishing best practice recommendations for compliance, establish quality assurance program(s) and implement standard operating procedures to ensure high quality study conduct.

Key Responsibilities:

Regulatory Operations (40%)

• Oversee the Colorado Cancer Clinical Trials Office (CCTO) Regulatory, Compliance, and Quality program and unit operations to maintain UCCC's standing as a National Cancer Institute (NCI) - designated Comprehensive Cancer Center ; ensures adherence to all federal and institutional research standards and all pertinent regulatory agencies
• Leads the development and implementation of new initiatives for Regulatory and operational efficiencies
• Identify and mitigate barriers to oncology study access for research subjects, including researching document translation resources and ensuring compliance with IRB consenting policies.
• Direct and manage all regulatory study start-up, and maintenance activities ensuring that opening timelines are met and that regulatory compliance is maintained across the studies operating in the CCTO
• Develops, implements, and maintains CCTO Policies and Procedures in relation to conducting multiple clinical research trials.
• Serves as committee member on University of Colorado Cancer Center (UCCC), Standard Operating Procedures (SOP) Group
• Serves as a liaison to Colorado Multi-Institutional Review Board (COMIRB), Western Institutional Review Board (WIRB), UCHealth Research Administration (RA), and all institutional oversight bodies and committees
• Develops corrective and preventative action plans in response to audits and internal quality control reviews with Compliance and Quality Program Manager
• Manages workload balances acuity across multiple teams and ensures regulatory research staff coverage is adequate to serve the needs of the Cancer Center

Strategic Forecasting (40%)

• Creates team objectives to meet UCCC's overall strategic goals with guidance from Cancer Center Clinical Operations Director
• Provides leadership for the development, implementation and maintenance of a clinical research quality and compliance program for the CCTO with attention to proactive systems, strategies and processes aimed at elevating clinical research excellence in all clinical research teams
• Recommends strategies, systems, and processes to support essential oversight activities.
• Collaborate across the Cancer Cener and CU Anschutz regulatory and compliance departments to build consensus and gain support for policies and processes within the CCTO
• Establishes and implements goals, objectives; monitors and evaluates operational effectiveness and effects changes required for improvement

Personnel Management/Fiduciary Responsibilities (20%)

• Manages CCTO Regulatory program budget to ensure accurate allocation of funds and unit services; forecasts needs on an annual basis
• Responsible for hiring, evaluation and discipline of Regulatory Managers and staff while ensuring day-to-day activities of the program are appropriately executed

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 1-2 days per week on campus and as needed for in-person meetings.

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."

Benefits statement to include in all benefits-eligible positions:

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

Diversity and Equity:

Equal Opportunity Employer. The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination 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.

Qualifications:

Minimum Qualifications:

• Education Requirement: A bachelor's degree in public health, public administration, public policy, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, communications, or a directly related field from an accredited institution.
• Experience Requirement: Six (6) years of clinical research regulatory experience that includes at least three (3) years of direct supervision of staff.

A combination of education and related professional experience may be substituted for the bachelor's degree on a year-for-year basis.

Applicants must meet minimum qualifications at the time of application.

Conditions of Employment:

Certification is required within one year of employment (one of the below):

• CCRC - Certified Clinical Research Coordinator
• CCRP - Certified Clinical Research Professional
• CCRA - Certified Clinical Research Associate

Preferred Qualifications:

• Experience working simultaneously with various sponsors and studies in multiple phases
• Experience working in an academic medical setting
• Oncology clinical research experience
• Experience in teaching, precepting and mentoring employees to clinical research
• Experience with Advarra OnCore and Advarra eReg
• Experience in clinical trial regulations and regulatory affairs
• Experience managing a remote team or working in a remote/hybrid environment

Knowledge, Skills, and Abilities:

• Ability to communicate effectively, both in writing and orally.
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills.
• Excellent interpersonal communication, organizational skills, and ability to problem solve and manage multiple priorities and deadlines.
• Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.
• 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, and NCI common toxicity definitions.
• Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology

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 (only use if a cover letter is necessary)

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: Cole Sprague, cole.sprague@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by April 15, 2025. 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 (minimum - 40^th posting max).

$88,896-104,008

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

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.