Senior Clinical Research Coordinator at UCSF

San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Aug, 26

Salary

58.41

Posted On

13 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research Coordination, Project Management, Patient Recruitment, Regulatory Compliance, Financial Analysis, IRB Administration, Contract Negotiation, Data Management, Audit Preparation, Risk Management, Clinical Trial Management, Interpersonal Communication

Industry

Hospitals and Health Care

Description

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.

Responsibilities

The Senior Clinical Research Coordinator is responsible for the overall operational management and administration of complex clinical studies, including the REACH Study. This includes overseeing IRB approval, subject recruitment, financial oversight, and ensuring compliance with FDA and NIH regulations.