Sr. CRC - Cancer Immunotherapy Research & Clinical Translation (CIRCT) University of California San Francisco - 4.1 San Francisco, CA Job Details 5 hours ago Qualifications Project team coordination Financial forecasting Contract review Clinical trial risk management Team leadership Operations coordination Financial management report preparation Contract management experience in healthcare Schedule management Managing budgets in a finance role Audit risk assessments Financial projection model development Implementing research protocols Project contract management Financial forecasting analysis Quantitative analysis Clinical program risk management Research and development project management Project planning phase Academic research compliance projects Organizational budget management Audit support

Full Job Description Job Summary:

Senior Clinical Research Coordinators with the Cancer Immunotherapy Research & Clinical Translation (CIRCT) program 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. This Senior Clinical Research Coordinator will support the Cancer Immunotherapy Program (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 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, Institutional Review Board (IRB), human resources, contracts and grants) and elsewhere (industry sponsors, coordinating centers, FDA, NIH), exhibiting an in-depth knowledge of specific programs. Reporting to the Clinical Research Manager, the incumbent 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 Overview:

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; or equivalent experience/training Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire Significant project and clinical trial management experience or progressively responsible experience in a related position including regulatory and compliance responsibilities In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures Experience using database software, such as MS Access or FileMaker Pro Financial analysis skills; demonstrated skills in preparing and presenting financial and quantitative analyses, including financial projections and budgets Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects 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

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 License/Certifications:

Ability to obtain certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals within one year of date of hire