Clinical research supervisor

The Helen Diller Family Comprehensive Cancer Center (HDFCCC) is seeking a Clinical Research Coordinator Supervisor for the Department of Surgery in the Breast Care Center Program. Under supervision of the ISPY Program Project Director, the CRC Supervisor is tasked with managing and facilitating the day-to-day operations of their direct reports including training and supervising a team of three to six CRCs. The CRC Supervisor is responsible for 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 CRC Supervisor assists the Director in resolving operational, workload, protocol implementation, and data collection issues for Phase I, II and Phase III studies. The candidate will be a proven team-player with project management skills and mindset and can consistently deliver results on a tight timeline. The CRC Supervisor will work with the Director to develop standard operating procedures and is responsible for training and mentoring CRCs to coordinate studies per Good Clinical Practice, with the goal to achieve optimal efficiency and productivity without jeopardizing patient care and data integrity. The individual will be a team player and assist with projects and patient coverage.

More specifically, the two studies, sponsored by QuantumLeap HealthCare, are the ISPY 2 trial and the DCIS/RECAST trial. The I-SPY trial involves novel trial designs in the setting of neoadjuvant chemotherapy to accelerate the drug development process. Our goal is to introduce and rapidly test novel targeted strategies for women at high risk for recurrence, at the time of primary cancer diagnosis, rather than waiting until they develop metastatic disease. 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, a phase 2 adaptive randomization trial. It is a unique public/private partnership between QuantumLeap Healthcare Collaborative and the National Cancer Institute (NCI), the Food and Drug Administration (FDA), patient advocates and over 40 major cancer research centers across the United States and Canada. The DCIS: RECAST Phase 2 trial assesses whether active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease, and is open at 24 locations across the United States.

Department Overview

The UCSF Breast Care Center (BCC) is a nationally recognized leader in breast cancer research. 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. Our goal is to introduce and rapidly test novel targeted strategies for women at high risk for recurrence, at the time of primary cancer diagnosis, rather than waiting until they develop metastatic disease. 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, 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.

RESPONSIBILITIES

Key Responsibilities

• Distributes work. Monitors the progress of work of assigned staff. Researches and resolves issues and discrepancies. Manages subordinates' quality and quantity of work to ensure unit meets its objectives. Reports performance evaluation to management.
• Supervises the timeliness and quality of data collection, submission and completion. This includes training new study coordinators in collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events and protocol adherence to federal regulations.
• Train, supervise, CRCs in coordinating clinical studies emphasizing the priority of patient safety and timely data reporting for industry sponsored, and Investigator-sponsored studies while maintaining scientific integrity of the study.
• Train, supervise, CRCs for reviewing medical history, performing study procedures, collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events, using medical charts and electronic records to extract medical information, and utilizing various data collection instruments including databases of sponsored studies, OnCore, iMEDris, Open Clinica, and Apex EMR.

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