Helen Diller Family Comprehensive Cancer Center
Full Time
61589BR
Job Summary
The Senior Clinical Research Coordinators (Sr. CRC) with the Cancer Immunotherapy Program (CIP) will 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 Sr. CRC will support CIP with primary responsibilities focusing on Parker Institute for Cancer Immunotherapy (PICI) clinical trials. PICI’s mission is to accelerate the development of breakthrough immune therapies to turn cancer into a curable disease.
The position is responsible for, and critically important to the overall operational management of clinical research activities. It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both National Institutes of Health - NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository. Positions at this level may 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 - CHR, human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, Food & Drug Administration - FDA, NIH), exhibiting an in-depth knowledge of specific programs.
Reporting to the Clinical Research Manager, the individual may have central responsibility for ensuring IRB approval and compliance, contract generation, negotiation and approval, subject recruitment, appropriate study testing, and adequate enrollment of multicenter clinical trials, longitudinal cohort studies, local investigator-initiated studies, and biorepository efforts; exercise strong administration and management leadership of clinical research, strong research coordination, and 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 Description
The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is a national leader in oncology research. The HDFCCC clinical research program is a fast-paced program with a broad portfolio of clinical trials. The mission of the UCSF HDFCCC clinical research program is to provide patients and their families with streamlined access to cutting-edge cancer therapies. In addition to providing compassionate, patient-centered care, our team of clinicians and researchers is dedicated to improving outcomes for all patients.
The Parker Institute for Cancer Immunotherapy (PICI) mission is to accelerate the development of breakthrough immune therapies to turn cancer into a curable disease.
Required Qualifications
• Bachelor's degree in related area and/or equivalent experience/training
• Certification by the Society of Clinical Research Associates or Association of Clinical Research Professionals, or ability to obtain certification within 1 year of date of hire
• 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
• 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
• Clinical research experience and demonstrated skills to successfully perform the assigned duties and responsibilities
• 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
• 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
• Demonstrated leadership qualities and ability to work constructively with others
• Highly proactive, attentive to detail, well-organized, proven ability to multitask and meet deadlines
Note: Physical/health screening required.
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 the location
• Experience with UCSF Helen Diller Family Comprehensive Cancer Center research process with the proven ability to work both independently and seek information from appropriate sources when needed in order to maintain human subject safety and data integrity
• Excellent written and verbal communication skills
• Experience with oncology project management with a proven ability to work with UCSF Medical Center staff of differing professional levels
• Experience with genitourinary oncology protocols
• Experience with training others in oncology clinical trials coordination
• Experience within the Investigational Trials Resource department of the HDFCCC
• Experience with Oncore and UCSF’s electronic medical record system, Apex
License/Certification
• Certification by the Society of Clinical Research Associates or Association of Clinical Research Professionals, or ability to obtain certification within 1 year of date of hire
About UCSF
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. We bring together the world’s leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.
Pride Values
UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence – also known as our PRIDE values.
In addition to our PRIDE values, UCSF is committed to equity – both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu
Join us to find a rewarding career contributing to improving healthcare worldwide.
Equal Employment Opportunity
The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Job Code and Payroll Title
007889 CLIN RSCH CRD SR NEX
Job Category
Research and Scientific, Supervisory / Management
Bargaining Unit
University Professional Technical Employees – Research Support Professionals Unit (UPTE-RX)
Location
Mission Bay (SF), Parnassus Heights (SF)
Additional Shift Details
Monday - Friday, 8 hours per day
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