University of Colorado Clinical Research Supervisor (Breast) in Aurora, Colorado
University of Colorado | CU Anschutz Medical Campus
School of Medicine, The Cancer Center
Clinical Research Supervisor (Breast) (Research Services Program Manager)
Position #696083 – Requisition #19606
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers
- The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.
The Cancer Center has an opening for a full-time University Staff (unclassified) Clinical Research Supervisor position.
The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here. at https://www.cuanschutz.edu/docs/librariesprovider15/default-document-library/2019-facts-brochure_web.pdf
The University of Colorado (CU) Cancer Center headquartered at the Anschutz Medical Campus and part of the CU School of Medicine. It is Colorado’s only National Cancer Institute-designated comprehensive cancer center at http://www.cancer.gov/researchandfunding/extramural/cancercenters , a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center’s clinical care sites are UCHealth, University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report.
The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network® at http://www.nccn.org/ , an alliance of the nation’s leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN) at http://www.oriencancer.org/ , a unique research partnership among North America’s top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center includes six institutional partners made up of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.
The CU Cancer Center’s vision is to “prevent and conquer cancer. Together. ” We do this through our mission statement of “uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care and education.”
Nature of Work
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.
Clinical Research Manager
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 and Benefits:
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/153125
Diversity 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 firstname.lastname@example.org.
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
Substitution: Closely related experience in a medical, clinical, research or clinical research environment may substitute for the degree on a year-for-year basis.
Required: Applicants must meet minimum qualifications at the time of hire.
Conditions of Employment
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, 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
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.
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.
Job: Research Services
Primary Location: Aurora
Job Category Research Services
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Nov 19, 2020
Unposting Date Ongoing
Posting Contact Name Melanie Schwartz
Posting Contact Email email@example.com
Posting Number 00696083
Req ID: 19606
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.