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About the Role

The Clinical Research Coordinator Supervisor will manage and facilitate the day-to-day operations of their direct reports, including training and supervising a team of three to six CRCs. This role involves training and evaluating CRC performance in executing studies, direct oversight of data collection and reporting, and implementation of protocols within the program that meet federal, state, and institutional policies and guidelines. The supervisor will assist in resolving operational, workload, protocol implementation, and data collection issues for Phase I, II, and Phase III studies.

Responsibilities

Distributes work, monitors progress, researches and resolves issues, and manages subordinates' quality and quantity of work.
Supervises the timeliness and quality of data collection, submission, and completion, including training new study coordinators.
Trains and supervises CRCs in coordinating clinical studies, emphasizing patient safety and timely data reporting.
Trains and supervises CRCs for reviewing medical history, performing study procedures, collecting source documentation, and using various data collection instruments.
Ensures compliance with internal policies and processes, trains employees on research regulatory processes, and implements defined research study processes.
Acts as a resource to CRCs for eligibility verification, study startup, and troubleshooting logistics.
Serves as a liaison between staff and program leaders, reporting work effort to the department.
Works with the Clinical Research Manager and CRC team to implement needs assessments and recommendations for enhancements.
Fields questions, explores issues, and supports CRCs in problem-solving.
Initiates clinical trial studies, oversees and reviews study systems and forms, and reviews accrual and eligibility.
Assures studies are carried out according to regulations, initiates and follows up on iRIS submissions, and maintains regulatory documents.
Monitors and audits visits, oversees and assists study coordinators in preparing for audits, and ensures data is sufficient and updated.
Trains, supervises, and guides CRCs to prepare for monitoring and audit visits.
Reviews and analyzes monitoring and audit reports to ensure action items are completed.
Identifies and addresses key areas for improvement related to training and performance management.
Tracks patient charges and alerts the department on billable triggers.
Trains, supervises, and guides CRCs to consult and interpret coverage analyses and communicate billing practices.
Recommends salary actions, promotions, and terminations.
Participates in the recruitment and orientation of new employees.
Evaluates assigned staff performance and reports to management.
Acts as backup for CRCs to cover operations as needed.

Requirements

Bachelor's degree in a related area.
Two years of experience with breast cancer clinical trial coordination.
Minimum of one year of related experience.
Minimum of one year of Lead/Supervisory/Manager experience.
Working knowledge of clinical or laboratory research, including clinical trial recruitment, eligibility, protocol adherence, quality data submission, and adverse event reporting.
Ability to manage multiple priorities, prioritize projects, adapt to changing priorities, and meet the demands of a fast-paced and dynamic work environment.
Demonstrated skills in employee supervision and HR administration, including experience training others, particularly in research.
Critical thinking and problem-solving skills to evaluate issues and identify potential solutions.
Clear and concise verbal and written communication skills.
Strong interpersonal, teamwork, leadership, mentorship, and motivational skills.
Ability to cultivate relationships with multiple stakeholders at various levels of administration.
Ability to perform commonly applicable word processing and spreadsheet functions.
Effectively use campus clinical information and documentation applications.
Proven ability using clinical trial management systems.

Skills

Project management
Clinical trial coordination
Supervision
HR administration
Training
Critical thinking
Problem-solving
Communication (verbal and written)
Interpersonal skills
Teamwork
Leadership
Mentorship
Motivational skills
Word processing
Spreadsheet functions
Clinical information and documentation applications
Clinical trial management systems

Location

San Francisco, CA

Work Type

Full-time

Experience Level

Supervisor
Lead

Education Level

Bachelor's degree
Advanced degree (preferred)

About the Company

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a nationally recognized leader in breast cancer research.
The UCSF Breast Care Center (BCC) is a unit within the Division of Surgical Oncology, in the Department of Surgery.
The BCC's clinicians are actively engaged in studies to advance all aspects of breast care including prevention, diagnosis, treatment, and improving quality of life.
They are also engaged in designing new processes for health care delivery, customized to the needs of individual breast cancer patients.
The BCC Research Program employs 55+ full-time faculty and staff, as well as associated subcontractors and consultants.
The I-SPY Program (managed within the BCC) involves novel trial designs in the setting of neoadjuvant chemotherapy to accelerate the drug development process.
The goal is to introduce and rapidly test novel targeted strategies for women at high risk for recurrence, at the time of primary cancer diagnosis.
Neoadjuvant therapy allows visualization of tumor response to treatment, and thus is the ideal platform to identify mechanisms of resistance, develop diagnostic markers, and individualize therapy.
I-SPY 2 is a phase 2 adaptive randomization trial process that will test up to 12 new drugs in approximately 800 patients over 5 years.
I-SPY 2 is a unique public/private partnership between Quantum Leap Healthcare Collaborative and the National Cancer Institute (NCI), the Food and Drug Administration (FDA), patient advocates and over 45 major cancer research centers across the United States and Canada.