Manager, Research Laboratory Operations

Tennessee Oncology, one of the nation’s largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology’s mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege.

Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.

Job Description:

The Research Laboratory Operations Manager is responsible for the overall management, coordination, and oversight of daily laboratory operations to ensure efficient, compliant, and high-quality research activities. This role provides leadership in operational planning, resource allocation, and process improvement to support research objectives and regulatory compliance. The successful candidate will have strong organizational skills and experience in facilitating operational aspects of a clinical research laboratory.

ESSENTIAL FUNCTIONS:

• Provides direct supervision, training, and technical support to the research lab team.
• Maintains knowledge and implementation of all rules, regulations, laws, and policies relating to laboratory processing and research sample management.
• Develops and maintains the operating procedures for the research lab; interprets and ensures consistent application of policies; assures compliance of the laboratory with outside regulatory agencies.
• Ensures maintenance of required laboratory records for all required inspections.
• Orders and maintains supplies for the laboratory following a cost-effective process.
• Ensures complete and accurate tracking and logging of samples received by the laboratory for processing and storage.
• Ensures that blood samples are processed appropriately according to the terms in the clinical trials and research agreements.
• Establishes and maintains systems/processes to manage the inventory of samples to include sample information and freezer locations.
• Ensures the proper distribution and shipment of samples for clinical research protocols.
• Verifies that quality assurance (QA) procedures and programs are following inspection standards/requirements.
• Ensures oversight of competency program and maintenance of required records and reports
• Assists in the preparation for, and coordination of, outside regulatory inspections, as required.
• Ensures that all personnel adhere to all internal and regulatory body policies, procedures, practices, and laws.
• Develops mechanisms to monitor compliance and quality.
• Assists in resolving any lab related issues that may arise during the conduct clinical research protocols.
• Ensures that all processes are performed in the most efficient, high-quality manner.
• Submits information and reports as required.
• Coordinates budget activities for the lab
• Monitors and analyzes expenses for lab.
• Develops and analyzes productivity measures.
• Compiles reports on productivity and budgetary expenses for lab.
• Makes recommendations for the purchase of new lab equipment.
• Utilizes institutional resources appropriately.
• Serves as lead representative for the research lab, attends and participates in meetings.
• Works with Executive Director to monitor workflow for changes in staffing, testing volume, equipment, supply needs.
• Performs other related duties as assigned to meet the goals and objectives of the department and institution.

EDUCATION & EXPERIENCE:

• Minimum of 3 years’ experience with two years of supervisory experience
• Must hold a valid Tennessee Medical Laboratory license, supervisor preferred.
• Bachelor's degree or equivalent experience required.
• Understanding of CAP, CLIA, and other local, state, federal regulations