Director for Biofluids Core

Clinical Operations Leader For Biospecimen Collection

We seek an experienced, strategic leader to oversee clinical operations for biospecimen collection in support of cancer clinical research. This role is responsible for managing the operational, scientific, and regulatory oversight of biospecimen collection and other preanalytical biobanking activities, including the collection and handling of blood, tissue, saliva, stool, bone marrow specimens, and research-related EKGs. 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 include:

• Overseeing 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.
• Developing, implementing, and optimizing standard operating procedures, workflows, and technical processes to improve operational efficiency and research quality.
• Managing and mentoring research staff, including hiring, performance management, staff development, and oversight of method development and laboratory operations.
• Collaborating with financial services to establish and manage fee structures and user fees for laboratory and biobanking services.
• Reviewing clinical trial protocols for feasibility and billing intensity scoring.
• Serving as the key collaborator with HTRC to help in inspections, safety audits, and compliance monitoring activities.
• Preparing and reviewing data compliance reports for leadership, focusing on protocol deviations/violations and planned corrective and preventive action plans.
• Developing goals, operating procedures, and clinical research guidelines aligned with UChicago Medicine Comprehensive Cancer Center strategy (UCCC), and institutional priorities.
• Adapting UCCCC priorities and resources to address operational challenges and support evolving clinical research demands.
• Managing research professionals and support staff involved with planning, monitoring, and compliance aspects of research projects. Advising other researchers on long-range plans for research projects.
• Developing goals and operating procedures, practices, and guidelines for research activity based on department strategy.
• Managing the laboratory facilities, including the purchase of new equipment and the maintenance and repair of laboratory equipment.
• Reviewing research of others, and may conduct own research, in area of expertise. Edits and approves articles, reports and manuscripts. Presents research findings at meetings and/or conference. Manages the research of processes in clinical or non-clinical settings. Program and use computers to store, process, and analyze data.
• Performs other related work as needed.

Minimum qualifications include a college or university degree in a related field and 7+ years of work experience in a related job discipline. Preferred qualifications include a Master's Degree in a related field, at least 10 years of experience operating and managing core facilities and research labs, and 7-10 years of independent policy-based decision-making.

Preferred competencies include strong communication, organizational skills, and attention to detail, adaptability, problem-solving, dedication to the team mission, experience handling confidential and sensitive data with discretion, ability to work independently and cooperatively with team members, and knowledge of Microsoft Excel, Word, PowerPoint, and Outlook. Familiarity with graphing software (SigmaPlot and GraphPad) is also preferred.

Working conditions include the ability to navigate the UChicago Campus as required by the position and hybrid work arrangements may be considered.

Application documents required include a resume (required) and cover letter (preferred). When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

This role is part of the research job family, a people manager with scheduled weekly hours of 40. Drug and health screenings are required. The pay range for this role is $110,000.00 - $150,000.00. The University of Chicago offers a wide range of benefits programs and resources for eligible employees.