CAP Laboratory Director (Clinical Trial Laboratory)

Regulatory, Trial, and Accreditation Leadership

• Serve as the legally accountable CLIA High-Complexity Laboratory Director and maintain qualifications per 42 CFR §493.1443.
• Provide executive oversight of CAP accreditation, including biennial inspections, self-inspections, and adherence to CAP checklist requirements.
• Ensure all laboratory operations supporting clinical trials meet CLIA, CAP, GLP, ICH-GCP, and GCLP expectations for accuracy, integrity, and traceability.
• Oversee trial-specific regulatory documentation, method validations, equipment qualifications, and assay change controls consistent with CAP validation/verification principles.

Clinical Trial Scientific Oversight

• Review and approve test methods, protocols, analytical plans, policies, procedures, and assay validations specific to clinical trial endpoints.
• Ensure test systems are suitable for the study population and meet clinical trial protocol requirements, consistent with CLIA’s requirement for appropriate test systems and reliable data.
• Serve as scientific liaison to sponsors, CROs, principal investigators, and regulatory authorities regarding laboratory capabilities, biomarker strategies, and test result interpretation.

Quality Management & Data Integrity

• Adhere to Quality in accordance with the ECL Quality Management System supporting clinical trial labs, including document control, method validation, instrument qualification, and ongoing competency assessments.
• Oversee proficiency testing (PT), quality control, and data integrity processes for trial-critical assays, meeting CLIA/CAP expectations for PT integration and evaluation.
• Approve CAPA plans and deviations relevant to clinical trials and ensure compliance with protocol-specific quality and audit requirements.
• Oversee day-to-day function of Laboratory and Specimen Management operations.
• Adhere to adequate Private Health Information (PHI) practices and policies.

Clinical Trial Operational Oversight

• Ensure laboratory workflows support GCP-compliant chain-of-custody, blinding, documentation, metadata capture, and audit trails.
• Partner with project management teams to ensure lab readiness, study startup timelines, sample logistics, and database lock requirements.
• Oversee Laboratory Information System (LIS) and study-specific data integrations supporting sample tracking, eCRF data flows, and regulatory compliance, aligned with CAP expectations for LIS management.

Personnel & Competency

• Ensure all laboratory staff involved in clinical trial testing meet CLIA/CAP qualifications and any elevated state requirements (NY CQ categories, CA LFS licensure, etc.).
• Provide oversight of personnel competency assessments and continuing education tied to trial-specific techniques. (General competence requirement)
• Support training in GCP/GCLP, protocol adherence, and data integrity.