CLIA Laboratory and Medical Director

Job Description

Job Description

SAGA Diagnostics is a personalized cancer diagnostics and disease monitoring company focused on molecular genetic analysis of circulating tumor DNA (ctDNA). The company’s mission is to improve precision cancer medicine, provide more accurate treatment monitoring, and improve patient survival using minimally invasive liquid biopsy cancer testing services. SAGA’s proprietary tests can help patients, oncologists, and drug developers detect actionable mutations, stratify patient groups, and monitor treatment response, residual disease, and disease recurrence at unprecedented sensitivity and scale. SAGA Diagnostics recently established a US operation in Research Triangle Park (RTP) and is excited to invite you to join our dedicated team.

The CLIA Laboratory and Medical Director is responsible for ensuring the delivery of quality clinical laboratory services. This position will serve as the CLIA Laboratory Director and be listed on the CLIA license. Specific responsibilities will include histology slide assessment, tissue selection, molecular assay interpretation and sign-out, assay development and validation, participation in laboratory operations, and improving digital pathology capabilities.

Essential Duties and Responsibilities :

• Responsibilities in operating the histopathology laboratory under CLIA, CAP, NYS, and all other applicable regulations.
• Responsible for slide review for tumor content estimation, diagnosis correlation, and communication with referring pathologists and oncologists if discrepancies arise.
• Participation in the quality management system, management of adverse outcomes and non-conformities, participation in onsite surveys, appropriate management of the results of the on-site survey, and performance in proficiency testing.
• Provide oversight of all aspects of the laboratory’s quality management system to ensure conformance to requirements described in the Quality Management System chapter of the Clinical Laboratory Practice Standards.
• Provide continuing education to laboratory technical staff that is relevant to laboratory medicine.
• Ensure that policies and procedures are established for monitoring staff to assess competency and, whenever necessary, provide remedial training or continuing education to improve skills.
• Promote a safe laboratory environment for personnel and the public.
• Ensure that an approved procedure manual is available to all personnel.
• Monitor all work performed in the laboratory to ensure that medically reliable data are generated.
• Assure that the laboratory participates in monitoring and evaluating the quality and appropriateness of services rendered, within the context of the Quality Management System, regardless of where the testing is performed.
• Provide advice to referring physicians regarding the significance of laboratory findings and ensure that reports of test results include pertinent information required for specific patient interpretation.
• Effectively implement a plan of correction for deficiencies identified.
• Report all concerns of test quality and / or safety to Supervisor or Safety Officer.
• Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments, and reagent / control / instrument qualifications, quality audits, deviation approval requests, and nonconforming event reports.

Requirements

Benefits

SAGA Diagnostics is an equal opportunity employer, fully committed to achieving a diverse and inclusive workplace that embraces and encourages applicants of every background. The company’s policy regarding equal employment opportunity means that all decisions regarding recruitment, hiring, benefits, wage and salary administration, scheduling, disciplinary action and termination will be made without unlawful discrimination on the basis of sex, gender, race, color, age, national origin, religion, disability, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, citizenship status, pregnancy or maternity, veteran status, or any other status protected by applicable federal, state or local law. If you require reasonable accommodation in completing an application, interviewing, or otherwise participating in the employee selection process, please direct your inquiries to hr@sagadiagnostics.com.