Clinical Research Manager

Description & Requirements

Job Description

Involves the development of and ensures compliance with clinical study protocols that involve human subjects. Oversees and resolves operational aspects of clinical studies or trials in conjunction with project teams and in accordance with standard operating procedures and good clinical practice and regulations. May be responsible for finances, clinical operations, and site and vendor selection.

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.

Qualifications

Required Qualifications - Bachelor's degree in 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. License/Certifications - Clinical Trial Professional certification from a professional society within one year in position. Preferred Qualifications - Advanced degree.