Senior Clinical Research Coordinator

The Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH Study) is a multi-center comparative, prospective, cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test. 
The Galleri test screens for many of the deadliest cancers before they become symptomatic, including those without recommended screening tests. The test results provide a predicted Cancer Signal Origin to help your healthcare provider determine the next steps for diagnosis This study will seek to enroll approximately 20% of the study participants from under-represented minority populations (e.g., racial / ethnic minority groups, socioeconomically disadvantaged populations, rural populations).

This study is being conducted across the nation, in which UCSF will be one of the research sites. The study will enroll approximately 50,000 participants aged 50 and older with Medicare coverage who will receive Galleri in addition to usual care as well as a passively-enrolled contemporaneous comparator cohort of approximately 50,000 Medicare beneficiaries who receive usual care without MCED screening.

Senior Clinical Research Coordinators with the Helen Diller Family Comprehensive Cancer Center 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 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 a Principal Investigator (PI) or Director, 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 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.

- Bachelor’s degree in related area and 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. - 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. 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