The CLIA Lab Operations Supervisor is responsible for performing and overseeing all standard laboratory operations in the Integrated Clinical Trials Pathology Laboratory (ICTPL), including training and managing ICTPL staff, maintaining CLIA regulatory documents and preparing for CLIA inspections.
SCOPE OF RESPONSIBILITIES
The incumbent reports to the Scientific and Medical Directors, and works independently in managing all aspects of laboratory functions within the framework of department, division and organizational policies and procedures. The successful candidate is highly-motivated, capable of working well with others as well as independently and able to motivate and supervise laboratory staff.
Collaborates with the Directors and other Principal Investigators to develop laboratory policies, systems, standard operating procedures and study-specific protocols for laboratory operations, ensuring compliance with quality, regulatory and other applicable guidelines.
Supervise laboratory staff including hiring, training, ongoing competency assessment, handling disciplinary action, layoff and termination issues; ensure training and orientation of new employees.
Oversee laboratory operations, providing guidance and taking corrective actions as needed to ensure quality, volume, regulatory and operational requirements and goals are met.
Establish QA/QC monitoring mechanisms to ensure that test procedures and results are performed, recorded, and reported promptly, accurately and proficiently.
Develop and administer lab policies and procedures related to operations and administration; oversee the laboratory quality improvement/quality assurance program and implement safety rules and regulations in compliance with institution, state and federal standards.
Collaborate with Directors to assist with forecasting, developing, monitoring and reporting on laboratory operating budget; ensure all related financial allocations and expenditures are in accordance with grant/contract guidelines.
Evaluate equipment and participate in negotiating related purchases and service contracts; plan for and ensure procurement of necessary reagents and supplies
Participates in long-term planning of laboratory operations including anticipation of staff and space needs, capacity planning and collaborations with other groups and/or investigators.
Communicate with clinicians regarding test requests, specimen handling, results and interpretation.
Maintain a thorough understanding laboratory’s scope of service and goals; participate in determining long range goals for project/program.
Work collaboratively with various internal and external departments and groups (regulatory oversight groups, FHCRC administration, funding agencies, external collaborators, vendors, subcontractors, etc.) as necessary to ensure operational success of the laboratory and related collaborations
Support study protocol development by assisting with research grant applications, providing insights in to technical laboratory needs, offering technical guidance to staff and other collaborators, as needed
Establish and maintain a continuing education program to educate staff on new or revised APOPs, new laboratory techniques and departmental policies and procedures
Minimum 5-10 years lab management experience; 2-3 years managing a CLIA histology lab while directing or supervising non-waived laboratory testing
Minimum 2 year’s experience performing immunohistochemistry, have prior experience developing high complexity IHC protocols and validating IHC protocols.
Bachelor’s Degree in the field of Laboratory Science or equivalent.
Certified or eligible for Board of Certification (BOC) by the American Society of Clinical Pathologists (ASCP) as a Medical Laboratory Technologist (MT), Histotechnologist (HTL) or Histotechnician (HT)
Thorough understanding of regulations applicable to a CLIA laboratory’s operations; experience with CLIA/CAP inspections; experience in assay validation and drafting of SOPs, with appropriate experience in molecular pathology methods that qualify as high complexity testing
Highly skilled in the areas of embedding, microtomy, grossing, special stains, and immunohistochemistry
Demonstrates leadership skills in a laboratory setting
Oral and written communication skills, with all levels of personnel
Qualification in Immunohistochemistry (ASCP- QIHC)
Advanced degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution (preferably accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)) as recognized under the 1988 Clinical Laboratory Improvement Amendments (CLIA) guidelines of high complexity testing
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