Assistant Director for Biofluids Core
University of ChicagoAbout the role
Department
BSD CCC - Clinical Trials Support Unit
About the Department
The UCCCC has one of the largest cancer clinical trials programs in the country and in the Chicago area, with more than 450 adult and pediatric therapeutic trials actively accruing patients. Many of these studies are investigator-initiated, including Phase I or I/II trials, demonstrating UCCCC's commitment to translating basic research findings to the clinic through proof-of-principle and early-phase studies. UCCCC opens over 130 new trials each year and accrues approximately 800 participants to therapeutic trials each year.
Job Summary
The individual will work closely with the Human Tissue Resource Center (HTRC) and the clinical trial operations teams, including Clinical Research Managers, Clinical Research Coordinators (CRCs), and Data Managers (DMs), to ensure execution of biospecimen-related protocol requirements across the full lifecycle of oncology clinical trials. This role will provide leadership for the CTSO Biospecimen Core, overseeing both research laboratory operations and associated administrative functions, while ensuring compliance with institutional, state, and federal regulations.
The position requires strong operational leadership, research oversight, and personnel management, including responsibility for collecting biospecimens, ensuring protocol compliance, managing fee-for-service operations, and developing new procedures to support evolving research needs.
Responsibilities
Oversees the development of service level agreements with HTRC that outline the sample processing and handling requirements, as well as other research-related activities that the CTSO Biospecimen Core will be responsible for overseeing.
Develops, implements, and optimizes standard operating procedures, workflows, and technical processes to improve operational efficiency and research quality.
Manages and mentors research staff, including hiring, performance management, staff development, and oversight of method development and laboratory operations.
Collaborates with financial services to establish and manage fee structures and user fees for laboratory and biobanking services.
Reviews clinical trial protocols for feasibility and billing intensity scoring.
Serves as the key collaborator with HTRC to help in inspections, safety audits, and compliance monitoring activities.
Prepares and reviews data compliance reports for leadership, focusing on protocol deviations/violations and planned corrective and preventive action plans.
Develops goals, operating procedures, and clinical research guidelines aligned with UChicago Medicine Comprehensive Cancer Center strategy (UCCC), and institutional priorities.
Adapts UCCCC priorities and resources to address operational challenges and support evolving clinical research deman
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