Helen Diller Family Comprehensive Cancer Center
The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC, or Cancer Center) is an interdisciplinary research center, part of a campus-wide multidisciplinary initiative with a goal of enhancing and integrating cancer related research and clinical care at UCSF. The Cancer Center is part of a network of 41 comprehensive cancer centers throughout the United States supported by the National Cancer Institute (NCI). It is led by a seven-member Directors Group and is comprised of 230 members working at the four major UCSF campus and hospital locations.
The Senior Clinical Research Coordinator in the Department of Radiation Oncology is responsible for, and critically important to, the overall operational management of the central nervous system (brain/spine) oncology trials program. The incumbent will assist the Lead Clinical Research Coordinator in implementing a diverse portfolio of research activities for one or more studies that includes multicenter, local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a prospective clinical database, bio-repository and other trials as assigned. This Senior CRC position will perform expert and efficient integration of multiple complex programmatic activities, applying a sophisticated medical knowledge base, substantial leadership skills, effectively working with a variety of people and organizations at UCSF (clinicians, investigators, clinical staff, administration, Committee on Human Research, human resources, contracts and grants) and elsewhere (universities participating in the multicenter trials, industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs.
The Senior CRC works under the direction of the Lead Clinical Research Coordinator-Supervisor and will provide regular status reports to the Principal Investigator (PI), this position will have responsibility to ensure CHR compliance; subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, local investigator-initiated studies, and biorepository efforts; assist in administration and management of clinical research, strong research coordination, and may lead experienced personnel to ensure optimal systems for efficiency, compliance, safety, financial oversight, , as well as create and implement quality improvement processes. This is a position whose main purpose is to ensure that CNS clinical research program commitments are met and that the program maintains a reputation for excellence in all activities.
The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.
• Bachelor’s degree, preferably in science or equivalent experience in related field
• Experience in developing SOPs. Ability to interpret and apply policies and regulations Two- three years experience managing clinical trials either at UCSF or at another company/institution; knowledgeable in the CHR or other IRB requirements as well as FDA regulations for human subject safety
• Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities.
• Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals
• Experience with various computer programs, like Microsoft Office, and clinical trial management systems
• Experience and knowledge in oncology medical care and oncology Phase I/II/III clinical trials. Knowledge of medical/oncology process and terminology; experience and knowledge of IRB policy and procedure; background in science/medicine preferably in hematology/oncology
• 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 trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting and all areas of GCPs
• Ability to assess and respond to audit risk; ability to develop project plans/schedules and motivate team to meet deadlines
• Ability to analyze complex and non-routine issues requiring innovative solutions
• Ability to operate effectively in a changing organizational and technological environment
Physical Demands: requires Able to sit and work at a computer for up to 8 hours/day; stand/walk for 3-6 hours; bend/stoop for up to 3 hours; reach for up to 3 hours; repetitive use of upper extremities for up to 8 hours; able to lift and/or carry 25 pounds; able to hear alarms, clients and/or instructions. Ability to see accurately from 20 inches to 20 feet; gripping/grasping, fine/gross finger manipulation; repetitive movements of upper and lower extremities; may be exposed to loud noises; dust, fumes or gases; chemical agents; tuberculosis, blood, body fluids or tissue, and radiological materials; latex, use protective equipment; differentiate color.
Note: Fingerprinting and background check required.
• Master’s degree in science
• Experience with radiation oncology treatment planning software Pinnacle and NIM
• Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF
• EExperience with UCSF clinical trial billing
• Experience with e-Medical Records, preferably EPIC /APeX
• Experience and knowledge in radiation oncology medical care and radiation oncology clinical trials. Experience with radiation oncology treatment planning software and digital data transmission
• Knowledge of and experience in administering cognitive tests (Mini Mental State Exam- MMSE, ADAS-Cog, NTB, etc) and Caregiver interviews such as Clinical Dementia Rating (CDR), Neuropsychiatric Inventory (NPI), and various other Health Outcome Assessments