CAP Laboratory Director (Clinical Trial Laboratory)

Eurofins•Lancaster, PA

2d•Onsite

About The Position

The Clinical Trial Laboratory Director provides scientific, medical, and regulatory leadership for high‑complexity laboratories supporting clinical research and clinical trials. This role ensures full compliance with CLIA requirements, including director qualifications and oversight responsibilities—and maintains CAP accreditation standards while meeting state-specific director/licensure requirements in multiple states, including Pennsylvania, New York, Rhode Island, Maryland, and California. The Director ensures assay validity, data integrity, patient‑subject safety, GDP, GLP. and GCP/GCLP‑aligned laboratory conduct throughout the lifecycle of clinical trials.

Requirements

Must meet one of the 42 CFR §493.1443 qualification pathways: MD/DO with state medical license and board certification in anatomic/clinical pathology (ABP/AOBP); or MD/DO/DPM with ≥2 years high‑complexity lab director/supervisor experience + ≥20 CE hours in director responsibilities; or PhD or equivalent with HHS‑approved board certification (e.g., ABB, ABCC, ABMM, ABMLI) + required leadership experience + ≥20 CE hours.
New York: Approved CQ categories for all testing performed; adherence to NY onsite/time requirements and director limits.
Pennsylvania: Qualifications per 28 Pa. Code §5.21.
California: Active LFS Laboratory Director (or specialty) licensure and personnel equivalency compliance.
Demonstrated leadership in GCLP/GCP‑aligned clinical trial laboratory operations.
Proven experience conducting method validations, instrument qualifications, and assay lifecycle management within regulated trial environments.
Prior interaction with sponsors, CROs, monitors, and regulatory audit teams (FDA, EMA, PMDA, CAP).
Demonstrated understanding of the EU In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746) and its impact on the design, validation, documentation, and post‑market oversight of in vitro diagnostic devices and tests.
Deep expertise in CAP checklists, CLIA personnel/testing rules, and director responsibilities.
Prior success leading CAP inspections under updated personnel rules (Dec 28, 2024 changes).
Strong command of GCP/GCLP quality requirements and clinical trial data integrity standards.
Ability to communicate scientific, regulatory, and operational requirements effectively to sponsors and internal teams.
Leadership skills in fast‑paced, audit‑intensive environments.
Experience with global multi‑site or multi‑state clinical trial laboratory networks.
Experience overseeing biomarker, pharmacokinetic, immunogenicity, genetic, or flow‑cytometry trial endpoints.
Maintain any state‑specific CE/licensure renewals (NY CQ, CA LFS).

Responsibilities

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.
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.
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.
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 start‑up 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.
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.
Support training in GCP/GCLP, protocol adherence, and data integrity.