Job Summary:

The Oncology Clinical Research Support Team (OCRST) provides comprehensive support for the Investigator-Initiated Trial (IIT) Program of the CU Cancer Center. The IIT Senior Manager is responsible for providing oversight of functional areas of the IIT Program including regulatory affairs, clinical project management, and clinical data monitoring. This position works closely with the OCRST Program Director, IIT Review Committee Chair, and IIT Incubator leadership team to define program objectives that align with the Cancer Center’s overall strategic goals, lead meetings and activities related to new IIT development, and support ongoing management of the study portfolio.

Key Responsibilities:

• 70% - IIT Program Oversight
• Oversee the IIT protocol opening process across all pipeline studies; serve as point of escalation and intervene as necessary to resolve obstacles.
• Hold regular meetings with IIT Program staff to review the IIT portfolio and status of studies in development, identify priorities or challenges, and intervene to ensure progress.
• Oversee IIT accrual monitoring activities, compile data for the IIT Review Committee on underperforming studies, and assist with follow-up activities as needed.
• Review IIT Site Selection and Feasibility Questionnaires, identify potential concerns or needed clarifications, and perform OCRST signoff.
• Review CAPA documents created by study teams in response to DSMC or other oversight entity requests prior to submission; suggest changes or clarifications as necessary to ensure responses are clear, thorough, and fully address identified issues.
• Ensure adherence to research standards set forth by the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), University of Colorado Hospital, CU Anschutz, National Cancer Institute (NCI), and other pertinent regulatory agencies.
• Identify the need for policies, procedures, and educational materials related to the IIT Program and work within the management team to develop, implement, and maintain OCRST policies and procedures for conducting IITs.
• Collaborate with the OCRST Finance Program Manager as needed during all phases of the study life cycle.
• Coordinate or oversee coordination of IIT Incubator and IIT Review Committee meetings; collaborate with the OCRST Program Coordinator in setting agendas and ensure proper tracking and follow-up activities are completed.
• 20% - Strategic Planning / Leadership
• Participate in system implementation and development of standards for use, including RedCap, Advarra EDC, eREG, project management software, and other systems.
• Provide regular reports to the OCRST Program Director and IIT leadership on program metrics, including study workloads and characteristics, opening timelines, and accruals.
• Develop internal relationships with CU Anschutz entities including CCTSI, CU Innovations, CRAO, clinical trial office/team leadership, and others that promote IIT development and operational success.
• Create team objectives to meet the Cancer Center’s overall strategic goals with guidance from the OCRST Program Director and Deputy Associate Director of Clinical Research.
• Collaborate with the Data Safety Monitoring Committee, Protocol Review Monitoring Committee, other OCRST program areas, and clinical trial office(s) on initiatives as needed.
• Attend and participate in leadership and management courses for growth and skill development.
• Support IIT Program growth; work with the OCRST Senior Manager to evaluate and define program capacity, forecast needs annually and develop job descriptions for new position needs.
• Lead process improvement and initiatives to improve efficiency and productivity within the IIT program.
• 10% - Personnel Management
• Support the management team with the supervision of IIT Program staff, including hiring, training, disciplinary actions, problem solving, and setting performance objectives.
• With input from the OCRST Program Director, handle personnel issues including interviewing, hiring, performance evaluations, counseling, and performance management; ensure appropriate staffing levels and conduct quality assurance audits of employee performance.
• Serve as a role model to OCRST staff by remaining in compliance with training requirements, meeting established deadlines, and maintaining a strong understanding of clinical research, regulations, operations, and ethics.
• Provide guidance regarding FDA and Good Clinical Practice regulations to OCRST staff, clinical research teams, and investigators.

Work Location:

Hybrid – this role is eligible for a hybrid schedule of 3 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.”

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: 15/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:

• Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution
• 5-7 years of professional experience, including clinical research experience and experience with Investigator Initiated Trials (IITs).
• Substitution: 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.
• Applicants must meet minimum qualifications at the time of application.

Preferred Qualifications:

• Oncology experience (clinical or research).
• Experience managing IIT programs, clinical research operations, or research administration.
• Experience with clinical trial regulations, GCP, FDA, IRB, and compliance requirements.
• Budgeting, contract management, and financial oversight experience.
• Three (3) years of experience providing leadership, supervision, mentoring, or oversight of staff, teams, and/or complex projects.

Conditions of Employment:

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).

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.
• Demonstrated commitment and leadership ability to advance diversity and inclusion.
• Excellent interpersonal communication and organizational skills, with the ability to problem solve and manage multiple priorities and deadlines.
• Understanding of the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ among 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.
• Demonstrated ability to supervise, mentor and manage staff, including performance management.

How to Apply:

For full consideration, please submit the following document(s):

• A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
• Curriculum vitae / Resume
• Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Bethany Baker

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by September 18, 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 $80,719 –$102,675. 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.

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 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.