CRSL Laboratory Manager
Listed on 2026-08-22
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Pharmaceutical
Regulatory Compliance Specialist, Medical Technologist & Lab Technician, Healthcare Compliance
Overview
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The Clinical Research Support Laboratory (CRSL) is the primary non‑CLIA certified laboratory responsible for collecting, processing, stabilizing, documenting, shipping, and tracking all research biospecimens from patients participating in clinical trials supported by the Yale Cancer Center Clinical Trials Office in New Haven at Smilow Cancer Hospital, as well as across the Smilow Cancer Hospital Cancer Center network.
The Laboratory Manager supports the growth and development of the Yale Cancer Center (YCC) CRSL and is responsible for executing procedural, managerial, and policy decisions. The Laboratory Manager will oversee the physical lab facilities and is accountable for managing laboratory equipment and supply levels to ensure cost‑effective, compliant, and efficient laboratory operations. This position is responsible for the development and maintenance of CRSL related policies and procedures and the CRSL quality control program.
Responsibilities- Oversee the daily operations of the CRSL laboratories, implementing standardized workflows.
- Develop and maintain policies and procedures to support the unit.
- Directly supervise Laboratory Supervisors and staff responsible for inventory of kits and lab supplies.
- Recruit, hire, conduct career development, performance evaluations, communicate deadlines and special circumstances, and administer disciplinary actions for direct‑report employees.
- Provide direct supervision for a staff of exempt and non‑exempt employees, ensuring appropriate staffing and resource levels.
- Represent the CRSL at relevant meetings and collaborate to develop and coordinate continuing education and training programs.
- Investigate complaints and collaborate with others to resolve issues arising within the unit.
- Assist in strategic and long‑range planning and budgeting processes.
- Provide study‑specific training at the time of subject enrollment and oversee CRSL staff to ensure adherence to study protocol.
- Coordinate with external sources to fulfill projects, keep abreast of new products and technologies, and arrange subcontractors.
- Evaluate work requests to determine appropriateness for the unit or another area.
- Coordinate with university personnel to define work assignments, communicate progress, and plan projects.
- Manage and maintain an inventory tracking system that streamlines CRSL distribution and operations.
- Maintain laboratory technology systems, equipment and supplies for the unit.
- Maintain equipment inventory and coordinate with appropriate departments and vendors for regular maintenance/service.
- Maintain knowledge of the regulatory environment governing the collection, storage, and shipment of human samples.
- Participate in local and international professional organizations, maintain best practices, and perform other duties as assigned.
Skills and Abilities
- Excellent interpersonal skills and the ability to relay information to and obtain information from internal staff as well as external study staff, with demonstrated ability to supervise and manage lab staff. Ability to think strategically, analytically, and influence constructive change with strong collaboration and relationship building skills.
- Demonstrated ability to ensure appropriate infrastructure by interpreting complex clinical trial protocols and lab manuals to evaluate the clinical, physical, technological, and staff resources required to guarantee trial conduct in accordance with the study protocol, applicable policies, and regulations while ensuring participant safety.
- Proven ability to work in a lab with advanced technical expertise in complex specimen processing procedures and familiarity with BSL‑2 laboratory standards; ability to travel to different laboratory locations.
- Excellent time-management and organizational skills; ability to meet daily deadlines while handling…
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