Compliance Program Manager

Job Summary:

The Quality and Compliance Program provides comprehensive support and oversight to the CU Cancer Center's oncology clinical research enterprise.

This Cancer Center position directly supports our strategic initiative to proactively identify, mitigate, and resolve compliance risks across all phases of oncology clinical research. The Compliance Program Manager partners with the Quality and Compliance Program Director, the DSMC Manager, the Cancer Center Learning and Development Manager, Assistant Director of Clinical Research, and Clinical Research Faculty leaders to create a culture of compliance by providing continuous guidance, training, and process improvement to all research teams across the Cancer Center.

Key Responsibilities:

Compliance Oversight: 40%

• Assists Quality and Compliance Program Director in defining compliance measures and metrics for CU Cancer Center clinical research.
• Develops and delivers training and education for research staff on compliance-related topics.
• Participates in the Cancer Center SOP work group and proposes revisions to applicable SOPs and new SOPs to increase compliance in clinical research.
• Recommends processes to support built-in quality checks for compliance; collaborates with the Cancer Center Learning and Development team and Clinical Research unit leadership teams to develop education courses and training for research teams across the Cancer Center.
• Facilitates communication with the DSMC Manager for internal audit findings and guides clinical research units in root cause analysis, CAPA development, and CAPA outcomes and revisions.
• Guides clinical research units in audit preparation, conduct, and follow-up
• Identifies the need for and drafts procedures and educational materials for improving research compliance.
• Ensures continuous process improvement and compliance. Subject matter expert to internal and external audiences regarding policies, procedures, and activities relevant to compliance program functions.

Strategic Planning/Leadership: 30%

• Participates in meetings with clinical research units (CHCO, VA, Gastroenterology) to assess compliance needs and measure the effectiveness of compliance-focused interventions..
• Assists the Quality and Compliance Program Director in tracking compliance measures and the success of key performance indicators.
• Designs and develops reports to demonstrate the accomplishments of the Compliance Specialists' interventions.
• With guidance from the Quality and Compliance Program Director, creates objectives for the Compliance team to meet the Cancer Center's overall strategic goals.
• Supports Compliance team growth and works with the Quality and Compliance Program Director to develop job descriptions for new position needs.
• Communicates changes from required research oversight committees (i.e., PRMS, UCH RA, OVCR, IRBs, IBC) to Compliance Specialists.

Personnel Management: 30%

• Responsible for hiring, onboarding, and training the Compliance Specialists.
• Ongoing supervision of Compliance Specialists, including training, disciplinary actions, problem-solving, and setting performance objectives.
• Conducts regular meetings with the Compliance Specialists to plan project priorities and solve challenges.
• Serves as a positive role model for all Compliance staff; complies with all training requirements, meets established deadlines, and possesses a working knowledge of clinical research regulations, Cancer Center SOP, and applicable guidelines.
• Ensures day-to-day activities and tasks are executed appropriately.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of approximately 1 day per week on campus in Aurora, CO and as needed based on business needs.

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:

• 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.
• Four (4) years of clinical research regulatory compliance or related experience, including at least two (2) years of supervisory responsibilities.
• Experience can substitute for a bachelor's degree on a year-for-year basis.

Preferred Qualifications:

• Oncology experience (clinical or regulatory)
• Experience working in an academic medical setting
• Research experience within a large hospital system
• Experience in teaching, precepting, and mentoring employees in clinical research

Knowledge, Skills, and Abilities:

• Effective delivery of training and facilitating communication between teams, both in writing and orally.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Excellent customer service and interpersonal skills.
• Ability to think critically, solve problems, and manage multiple priorities and deadlines.
• Strong organizational habits.
• Knowledge of organizational structure, workflow, and operating procedures.
• Understanding of computer systems (specifically MS Office Suite, Teams, and Smartsheets) and ability to work efficiently within various applications.
• Working knowledge of clinical trial guidelines and regulations to include Good Clinical Practices (GCP), FDA Rules and Regulations, ICH guidelines, and HIPAA regulations.

Applicants must meet minimum qualifications at the time of application.

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: sherri.wilke@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 30, 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

$71,994-$84,233

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 is not eligible for overtime compensation.

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 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.