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.
 

Required Qualifications:

•    BS/BA degree in a related area and/or equivalent experience/training. Sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities; and/or equivalent experience/training.
•    Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals.
•    In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
•    Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
•    Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal and written communication skills.  
•    Ability to analyze complex and non-routine issues requiring innovative solutions.
•    Ability to operate effectively in a changing organizational and technological environment.
•    Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines.
•    Ability to interpret and apply policies and regulations.
•    Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets.
•    Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
•    Experience using database software, such as MS Access or FileMaker Pro.
 

Preferred Qualifications:

•    Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up.
•    Experience in risk management regarding study subjects, federal and non-federal sponsors and regulating bodies.
•    Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF.
•    Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals.