Clinical Research Supervisor (Breast)
DescriptionUniversity of Colorado | CU Anschutz Medical Campus
School of Medicine, The Cancer Center
Clinical Research Supervisor (Breast) (Research Services Program Manager)
Position #696083 – Requisition #19606
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.Professional Field
Medical/Clinical Research Supervision Received
Clinical Research ManagerSupervision Exercised
This individual is responsible for the supervision, discipline, and evaluation of all members with her/his designated clinical research team(s). Examples of Work Performed
- 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.
- 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.
- 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.
- Work with finance team members to resolve discrepancies and to review account balances on a regular basis.
- 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, audit results.
- Maintains responsibility of the direct reports Profile Form and Delegation of Authority log oversight.
- 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.
Salary is commensurate with skills and experience 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: http://www.cu.edu/node/153125Diversity and Equity:
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 [email protected] The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.The University of Colorado Denver | 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.
- 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.
- 2 years of clinical research experience and 1 year of clinical and/or research experience
Certification required within 6 months of hire (one of the below):
- CCRC – Certified Clinical Research Coordinator
- CCRP – Certified Clinical Research Professional
- CCRA – Certified Clinical Research Associate
- Four (4) years of clinical and/or clinical research experience.
- One 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 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.
Job Category: Research Services
Primary Location: Aurora
Posting Date: Nov 19, 2020
Unposting Date: Ongoing