Senior Clinical Research Coordinator, Liver Biorepository

The Senior Clinical Research Coordinator independently coordinates and is accountable for the overall operation of the Ibrahim El-Hefni Liver Biorepository (IELB) and its associated clinical research studies at UCSF. Requiring advanced-level knowledge and skills, the incumbent serves as the operational and regulatory lead for the biorepository—overseeing biospecimen collection, processing, annotation, and distribution—and provides leadership to other clinical research coordinators and support personnel within the program.

This position is critically important to the operational management of the IELB and the liver disease research it supports. It has direct responsibility for managing a biospecimen repository—including blood, serum, plasma, and liver tissue linked to richly annotated clinical data—along with the longitudinal cohort studies and investigator-initiated protocols that feed it. The incumbent prepares and maintains IRB (CHR) applications and approvals, coordinates studies, and actively publicizes the biorepository’s available samples to investigators at UCSF and externally to maximize their scientific use. The role requires expert integration of regulatory, operational, and data-management activities, applying a sophisticated medical and immunology knowledge base and substantial leadership skills, and working effectively with clinicians, investigators, clinical staff, the Committee on Human Research, and contracts and grants staff at UCSF, as well as with external collaborators, sponsors, and NIH.

Reporting to the Principal Investigator/Director, the incumbent has central responsibility for ensuring IRB approval and ongoing compliance for the biorepository and its protocols; managing consent, specimen accessioning, inventory, and chain-of-custody; coordinating biospecimen requests and material transfers; and building and maintaining the IELB website to communicate available samples, governance policies, and request procedures to the research community. The incumbent also leads experienced personnel and implements quality improvement processes. This is a position of leadership whose main purpose is to ensure that the biorepository’s scientific, regulatory, and operational commitments are met and that the program maintains a reputation for excellence in all activities.

The Ibrahim El-Hefni Liver Biorepository (IELB) at UCSF is a translational research resource within the Department of Medicine dedicated to advancing the study of liver disease.. The IELB collects, processes, annotates, and stores high-quality biospecimens—including blood, serum, plasma, and liver tissue and makes these samples available to investigators across UCSF and the broader scientific community. By pairing rigorous regulatory and quality oversight with active outreach to the research community, the IELB accelerates discovery in liver biology and the development of curative therapies. We are a collaborative, mission-driven team seeking an experienced Senior Clinical Research Coordinator to lead the operational, regulatory, and biorepository activities of the program.

% 

of time  (Nothing less than 5%)

Essential Function (Yes/No)

Key Responsibilities

(To be completed by Supervisor)

20

Research Operations Management: 

• Develop project plans, interview key sponsors, and deliver tangible project results
• Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables
• Design and perform ad-hoc performance analysis of the projects and the project staff
• Build flexible pricing and cost models to test recommended solutions against a range of outcomes/scenarios within the clinic trials and research projects
• Perform business process review, operational reviews and design and implement workflow and controls
• Develop project-related presentation material for study
• Monitor key operating potential for risk to clinics, physicians, staff, and the University (e.g., inappropriate marketing, poor hiring practices, etc.)

20

Clinical Trials Management: 

• Serve as the primary regulatory coordinator for the biorepository and associated studies: prepare, submit, and maintain IRB (CHR) applications, continuing reviews, modifications, and safety reports; ensure all protocols, consent forms, and biospecimen collection activities remain in continuous compliance with IRB and institutional requirements.