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    Life Sciences

    CAP Laboratory Director (Clinical Trial Laboratory)

    Lancaster, United StatesOn-SiteFull-timePosted 1mo ago
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    Job description

    Role Summary: 

    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.

    Key Responsibilities

    1. 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.

    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 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.

    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 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.

    4. 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 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.

    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 trial‑specific techniques. (General competence requirement)
    • Support training in GCP/GCLP, protocol adherence, and data integrity.

    Required Qualifications

    Federal (CLIA High‑Complexity 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 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.

    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 Trial–Specific Qualifications

    • 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.

    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 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.

    Education & Continuing Education

    • Maintain any state‑specific CE/licensure renewals (NY CQ, CA LFS).

    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.

    Job details are sourced from the employer's original posting.

    Open job posting
    EU

    About the company

    Eurofins

    Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. Eurofins PSS Insourcing has an exciting and rewarding opportunity for a Business Development Manager to join our team.  We are searching for a business development professional with proven experience selling and implementing high-value sales.  Someone who thrives on identifying and closing new business caring for the client through the process will succeed in this role. This position offers the excitement of hunting for new clients with the goal of diversifying our offerings and client base as well as the opportunity to foster and expand partnerships with key clients.  This is a hybrid role working remotely from a home office, travelling locally and within the region for prospect and current client meetings as well as full days spent at current client sites to maximize networking and relationship building opportunities. A successful candidate will have a proven track record and is comfortable reaching out to and meeting with high level decision makers including C-Suite.  This position will manage the strategic sales process including identifying client needs, defining and presenting how PSS can address them, as well as managing the implementation process for new programs. If you’re looking for a rewarding career, a place to call home, apply with us today! 

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