Clinical Research Supervisor - Breast Oncology Program

About the role

The Clinical Research Supervisor will provide operational leadership to a team of Clinical Research Coordinators (~3-6 direct reports) in a fast-paced oncology clinical trials environment. This role involves strategic planning to meet program goals, ensuring reporting and study milestones—including recruitment targets, data entry timelines, budget, and sponsor requirements—are achieved. The successful candidate will collaborate with Principal Investigators, scientific oversight committees, and senior leadership to maintain high-quality service and consistency across disease programs.

The role also includes performance management, morale-building, and identifying training needs for staff. Duties may encompass coordinating single or multiple clinical research studies (sponsored, cooperative group, and investigator-initiated), acting as an intermediary between departments, overseeing data and specimen management, managing study results, maintaining databases, ensuring regulatory compliance, and participating in audits.

Responsibilities

• Provide operational leadership and supervision to a team of Clinical Research Coordinators.
• Monitor workload, productivity, and performance while maintaining team morale.
• Develop and implement strategic plans to meet program goals, including recruitment targets, data entry timelines, and budget requirements.
• Ensure compliance with regulatory agencies, including IRB and FDA regulations for human subject safety.
• Oversee study data integrity and implement quality control procedures.
• Coordinate staff work schedules and manage study assignments across disease programs.
• Act as an intermediary between services, departments, and stakeholders for clinical research studies.
• Manage and report on study results, including adverse event reporting per NCI/CTEP requirements.
• Create, clean, update, and manage databases and comprehensive datasets.
• Interface with departments to obtain UCSF approval prior to study initiation.
• Maintain regulatory documents in partnership with the Regulatory department.
• Report study progress to investigators and participate in internal/external audits.
• Train and mentor staff, identifying areas for development and refresher training.
• Perform other duties as assigned, including supporting the management of multiple clinical trials.

Requirements

• Bachelor’s degree in a related area.
• At least 2 years of experience with industry clinical trials as a Clinical Research Coordinator (CRC).
• At least 2 years of experience in project/program coordination, preferably in clinical trials at an academic or research institution.
• Clinical Trial Professional certification from a professional society within one year of hire.
• Working knowledge of clinical or laboratory research, including clinical trial recruitment, eligibility, protocol adherence, quality data submission, and adverse event reporting.
• Demonstrated experience in employee supervision and HR administration.
• Proven ability to train others, particularly in research settings.
• Strong critical thinking and problem-solving skills.
• Excellent verbal and written communication skills, with the ability to interact effectively with multiple stakeholders at various administrative levels.
• Proficiency in word processing, spreadsheet software, and clinical trial management systems.
• Knowledge of IRB requirements and FDA regulations for human subject safety.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.
• Physical ability to sit and work at a computer for up to 8 hours/day; stand/walk for 3-6 hours; bend/stoop for up to 3 hours; reach for up to 3 hours; repetitive use of upper extremities for up to 8 hours; lift and/or carry up to 25 pounds; and see accurately from 20 inches to 20 feet.

Preferred Qualifications

• Advanced degree.
• Experience and knowledge of medical care and Phase I-III clinical trials, preferably in oncology.

About the department

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area designated as “comprehensive” by the National Cancer Institute (NCI). HDFCCC integrates laboratory research, clinical research, patient care, and population research to advance cancer treatment and prevention. Research and treatment at HDFCCC are guided by the principles of precision medicine and precision population health.

Benefits

For information about the benefits of working at UCSF, including total compensation, visit: UCNet Benefits.