Job Summary:

The Cancer Clinical Trials Office (CCTO) is looking to hire a full time Clinical Research Supervisor. This position oversees clinical studies performed at the CU Cancer Center and directly supervises the clinical research staff.

Examples of Work Performed

40% Team oversight and training/personnel development

• Arranges orientation and provides training, supervision and leadership to the clinical research staff.
• Assigns patient and trials to staff with guidance from Clinical Research Manager.
• Supervises team vacation, out of office coverage, time management of direct reports.
• Monitors workload acuity with guidance from Clinical Research Manager.
• Assists clinical research staff with technical issues, problem solving and intervention when appropriate, delegates responsibility for elements of the conduct of selected clinical trials. Answers questions from clinical team including but not limited to study protocols, patient concerns, eligibility, scheduling conflicts, and department logistics.
• Makes recommendations regarding clinical research personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions with guidance from Clinical Research Manager. This would include letters of expectations being written and delivered to direct reports.
• Maintains responsibility of the direct reports Profile Form and Delegation of Authority log oversight.

40% Clinical Trial Management

• Acts as an interdepartmental liaison with UCH clinic staff (i.e. investigators, nurses, clinic support staff, laboratory, pharmacy, radiology).
• Plans and directs investigator and coordinator meetings including but not limited to team meetings, initial orientations, study audits, and closeout visits.
• Work with finance team members to resolve discrepancies and to review account balances on a regular basis.
• Assists in completion of Internal Protocol Amendment Review forms.
• Helps with amendment treatment plans through the UCHealth Beacon process and works with assigned RN for completion.
• Collaborates with OCRST, Oncology Clinical Research Support team on Investigator Initiated trials.
• Serves as primary clinical research coordinator and may carry a patient load as needed for team coverage and understanding of clinical tasks and job functions.
• Performs additional duties as assigned by clinical manager and/or clinical operations director.

20% Team quality assurance, Guidance Development, and Collaboration

• Participate in external audits and internal process improvement strategies to promote consistent best practices.
• Participates in reviewing and tracking deviation trends leading to review of processes.
• Assures compliance with all protocol details which includes ensuring the capture of all data points requested on a protocol-specific basis and ensuring that tests and procedures required by clinical protocols are performed and documented.
• Assures compliance with OnCore entries ensuring that accuracy is maintained.
• Performs quality assurance checks by reviewing patient shadow charts, monitor letters, and audit results.

Work Location:

Onsite - at the Anschutz Medical Campus in Aurora, CO

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.

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

Diversity and Equity:

DIVERSITY, EQUITY, INCULSION AND ACCESS

At the University of Colorado Cancer Center (CU Cancer Center), we deem diversity in thought, perspective, lived experiences, and backgrounds to be essential for understanding and providing world-class health and cancer care to our diverse patient populations. We are, therefore, committed to the intentional development of a diverse, equitable, inclusive, and respectful academic community and workplace. We actively encourage individuals of all races, religions, national origins, genders, gender expressions, sexual orientations, ages, as well as veterans and individuals with disabilities to apply for positions at the CU Cancer Center.

If you are an applicant with a disability, the University will provide reasonable accommodations throughout the employment application process. Please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu to request an accommodation in accordance with the Americans with Disability Act.

Qualifications:

Minimum Qualifications:

• 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. Closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.
• Two (2) years of clinical research experience and two (2) year of clinical and/or research experience.

Applicants must meet minimum qualifications at the time of hire.

Conditions 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

Preferred Qualifications:

• Four (4) years of clinical and/or clinical research experience.
• One (1) year of oncology research.
• Personnel management experience.
• Experience serving as a primary coordinator for clinical trials.
• Experience teaching, orienting and mentoring new employees to clinical research.
• Experience assisting in the development of policy, procedure or patient education materials related to clinical research.

Knowledge, Skills, and Abilities

• Knowledge of basic human anatomy, physiology, medical terminology.
• Advanced knowledge of GCP, 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.
• Proficient with Clinical Research Coordinator III duties/responsibilities.
• Excellent interpersonal and customer service skills.
• Excellent oral and written communication skills.
• Organization and time management skills.
• Leadership abilities.
• Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with National Cancer Institute (NCI) sponsored, private industry and investigator initiated clinical trials.
• Demonstrates the quick ability to learn, interpret and master complex protocol information.

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: Brandi Asheim, brandi.asheim@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by May 16, 2024. 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 $66,472 - $84,552.

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

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.