Clinical Research Supervisor (Breast ​/ Gyn

Clinical Research Supervisor (Breast / Gyn)

As an important member of the research team, the Clinical Research Supervisor will report to the team manager and work with Phase I-IV industry-sponsored, co‑operative group, and investigator-initiated clinical trials in accordance with trial protocols, FDA regulations, and ICH/GCP guidelines. The role is accountable for meeting study‑specific goals and timelines, assisting with clinical tasks related to study procedures and treatments, coordinating subject appointments, managing monitoring visits and audits, handling data entry and resolution, and advocating for study subjects.

• Arrange orientation and provide training, supervision, and leadership to the clinical research staff.
• Assign patients and trials to staff with guidance from the 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, orientations, study audits, and closeout visits.
• Make recommendations regarding clinical research personnel issues, including hiring decisions, performance evaluations, counseling, and disciplinary actions.

• Participate in reviewing and tracking deviation trends to improve processes.
• Perform quality assurance checks by reviewing patient shadow charts, monitor letters, audit results, OnCore entry, and data entry.
• Attend supervisor meetings, bring items from the team, and provide updates.

• 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.

Hybrid – 3 days per week on campus.

• Medical, dental, and multiple plan options.
• Additional insurance: disability, life, vision.
• Retirement 401(a) Plan: employer contributes 10% of gross pay.
• Paid Time Off – accruals over the year.
• Vacation Days: 22 per year (maximum accrual 352 hours).
• Sick Days: 15 per year (unlimited maximum accrual).
• Holiday Days: 15 per year.
• Tuition Benefit – available to employees on all CU campuses.
• ECO Pass – reduced rate RTD bus and light rail service.

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

• Oncology research experience and knowledge of basic human anatomy, physiology, and medical terminology.
• Intermediate to advanced Microsoft Office skills (Excel, Word, Outlook).
• Experience working with electronic CRF software programs.
• Experience with sponsors and audits.
• Additional certification (one of the following): CCRC – Certified Clinical Research Coordinator, CCRP – Certified Clinical Research Professional, CCRA – Certified Clinical Research Associate, CRC I – 5 CEUs, CRC II – 10 CEUs, CRC III – 15 CEUs.

• Applicants must be legally authorized to work in the United States without requiring sponsorship.
• Individuals must obtain and track continuing education regardless of whether they hold an additional certification (required annual levels).

• Analytical Skills – ability to interpret and master complex research protocol information.
• Attention to Detail – excellent attention to detail and ability to interpret and master complex research protocol information.
• Complex Problem Solving – identify complex problems, review related information, develop and evaluate options, and implement solutions.
• Communication Skills – good command of the English language, and ability to communicate effectively, both written and verbal.
• Interpersonal Skills – establish and maintain effective working relationships with employees at all levels; interact with people in a friendly, open, honest manner; model a commitment to teamwork; demonstrate respect for the opinions of others; and maintain a high level of confidentiality.
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