CAP Laboratory Director (Clinical Trial Laboratory)

Role Summary: 

The Clinical Trial Laboratory Director provides scientific medical and regulatory leadership for highcomplexity laboratories supporting clinical research and clinical trials. This role ensures full compliance with CLIA requirements including director qualifications and oversight responsibilitiesand 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 patientsubject safety GDP GLP. and GCP/GCLPaligned laboratory conduct throughout the lifecycle of clinical trials.

Key Responsibilities

1. Regulatory Trial and Accreditation Leadership

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

2. 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 CLIAs 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.

3. 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 trialcritical assays meeting CLIA/CAP expectations for PT integration and evaluation.
• Approve CAPA plans and deviations relevant to clinical trials and ensure compliance with protocolspecific 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.

4. Clinical Trial Operational Oversight

• Ensure laboratory workflows support GCPcompliant chainofcustody 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 studyspecific data integrations supporting sample tracking eCRF data flows and regulatory compliance aligned with CAP expectations for LIS management.

5. 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 trialspecific techniques. (General competence requirement)
• Support training in GCP/GCLP protocol adherence and data integrity.

Qualifications :

Required Qualifications

Federal (CLIA HighComplexity Director 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 highcomplexity lab director/supervisor experience 20 CE hours in director responsibilities; or
• PhD or equivalent with HHSapproved board certification (e.g. ABB ABCC ABMM ABMLI) required leadership experience 20 CE hours.

State Requirements (must meet the most stringent)

• 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.

Clinical TrialSpecific Qualifications

• Demonstrated leadership in GCLP/GCPaligned 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 postmarket oversight of in vitro diagnostic devices and tests.

Knowledge Skills & Abilities

• 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 fastpaced auditintensive environments.
• Experience with global multisite or multistate clinical trial laboratory networks.
• Experience overseeing biomarker pharmacokinetic immunogenicity genetic or flowcytometry trial endpoints.

Education & Continuing Education

• Maintain any statespecific CE/licensure renewals (NY CQ CA LFS).

Additional Information :

As a Eurofins employee you will become part of a company that has received national recognition as a great place to work!

Life at Eurofins is a meritocracy where people are empowered to make decisions and are rewarded for their success allowing them to advance quickly. Become your most extraordinary self with support and development throughout your career.

We offer excellent full-time benefits including comprehensive medical coverage life and disability insurance 401(k) with company match paid holidays vacation personal days and dental and vision options.

Eurofins is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.

All your information will be kept confidential according to EEO guidelines.

Remote Work :

No

Employment Type :

Full-time