Clinical Research Supervisor; Breast​/Gyn

Job Summary

As an important member of the research team, the Clinical Research Supervisor (Breast / Gyn) will report to the team manager. This position works with Phase I–IV industry-sponsored, cooperative group and/or investigator-initiated clinical trials in accordance with trial protocols, FDA regulations, and ICH/GCP guidelines. It is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on licensure and/or completion of competency documentation and team needs.

This position coordinates study subject appointments, schedules, and prepares for monitoring visits and audits. It is responsible for data entry and resolution, study subject advocacy, and possible management of studies at the local level.

• Under the manager's guidance, arrange orientation and provide training, supervision, and leadership to the clinical research staff.
• Assign patient and trials to staff with guidance from Clinical Research Manager.
• Supervise team vacation, out-of-office coverage, and time management of direct reports.
• Plan and direct investigator and coordinator meetings, including team meetings, initial orientations, study audits, and closeout visits.
• With guidance from the manager, make recommendations regarding clinical research personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions.

• Participate in reviewing and tracking deviation trends leading to process review.
• Perform quality assurance checks by reviewing patient shadow charts, monitor letters, audit results, data entry in OnCore, and related activities.
• Attend supervisor meetings and relay items from the team to the group, providing updates as needed.

• Maintain 2–5 study participants at any given time and manage day-to-day issues such as scheduling conflicts, infusion issues, and enrollment packet review under the direction of the CRM if problems escalate.

Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.

The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. It is the state’s only National Cancer Institute (NCI) designated Comprehensive Cancer Center, with a mission to unite the community to conquer cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education. We have more than 300 members including physicians and researchers, plus nearly 300 staff members who support research and patient care across various cancer types.

We offer comprehensive benefits including medical, dental, disability, life, and vision insurance; retirement plan; paid time off; vacation and sick leave; holidays; tuition benefits; and transit subsidies. There are additional perks and programs with CU Advantage.

• Bachelor’s degree in a related field (Science, Health, Business or Finance, Mathematics, History, Social Sciences, Arts, Communications, Education, Engineering, Human Services, Legal, or related fields)
• Two (2) years of clinical research experience and one (1) year of clinical or clinical research experience

Substitution:
Any equivalent combination of relevant education and experience can substitute for the degree on a year-for-year basis. Applicants must meet minimum qualifications at the time of application.

• Oncology research experience and knowledge of human anatomy, physiology, and medical terminology
• Intermediate to advanced Microsoft Office skills (Excel, Word, Outlook)
• Experience with electronic CRF software programs
• Experience with sponsors and audits
• Additional certification options include: CCRC, CCRP, or CCRA

• Applicants must be legally authorized to work in the United States without sponsorship. We are unable to provide work visa sponsorship now or in the future.
• Continuing education requirements apply…