Sr Clinical Research Coordinator Clinical Research Network Office

Job Summary: 

Senior Clinical Research Coordinators (Sr CRC) with the HDFCCC Clinical Research Network Office independently coordinate and are accountable for the overall administration of one or more clinical studies, typically requiring advanced-level knowledge and skills.  They may provide leadership to lower-level clinical research coordinators and/or other support personnel. The position will specifically work on the ISPY2 clinical trial and is responsible for and critically important to the overall operational management of the trial and the ISPY program at Cancer Center Berkeley (CCB).  

UCSF is the lead site for the I-SPY Program; the program 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. I-SPY 2 is a phase 2 adaptive randomization trial, that 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 40 major cancer research centers across the United States and Canada. Positions at Sr CRC level may perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, and effectively working with a variety of internal (clinicians, investigators, clinical staff, administration, Institutional Review Board (IRB), human resources, contracts and grants) and external (industry sponsors, coordinating centers, FDA, NIH) stakeholders, exhibiting an in-depth knowledge of specific programs.

The Sr CRC will perform independently or with general direction at the fully operational level of the series to execute, manage, coordinate research protocols, and train staff, as directed by the Principal Investigator (PI), Program Director, and Clinical Research Manager (CRM).The incumbent may have central responsibility for assisting with IRB approval and compliance, ensuring subject recruitment and adequate enrollment, executing research procedures, and developing site and study specific workflows. The Sr CRC exercises strong administration and management leadership of clinical research, strong research coordination, may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, and contractual expertise in negotiations and execution, as well as create and implement quality improvement processes. This is a position of leadership whose main purpose is to ensure that clinical research commitments are met and that the programs maintain a reputation for excellence in all activities.
 

Department Overview:

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute (NCI).
The HDFCCC integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.
 

% 

of time

Essential Function (Yes/No)

  

Key Responsibilities

(To be completed by Supervisor)

10

Yes

Research Operations Management: 

• Develop project plans, interview key sponsors, and deliver tangible project results
• Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables
• Design and perform ad-hoc performance analysis of the projects and the project staff
• Build flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic trials and research projects
• Perform business process review, operational reviews and design and implement workflow and controls
• Develop project-related presentation material for study
• Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.)

 

50

Yes