Part-Time CLIA Laboratory Director (Moderate-Complexity Lab)

LYV The Wellness Space

Part-Time CLIA Laboratory Director (Moderate-Complexity Lab)

Cleveland, OH
Part Time
Paid
  • Responsibilities

    Benefits:

    Employee discounts

    Flexible schedule

    Free uniforms

    Opportunity for advancement

    Training & development

    About Live Wellness Space Live Wellness Space is launching an in-house clinical laboratory to support advanced wellness diagnostics. Our lab will perform moderate-complexity immunoassay testing, including PSA, Total Testosterone, and Vitamin D. We are building a compliant, efficient, physician-office laboratory focused on quality, speed, and patient experience.

    Role Summary We are seeking a CLIA-qualified Laboratory Director to provide regulatory oversight and quality leadership for our moderate-complexity lab. This role is focused on compliance, documentation review, quality assurance, and inspection readiness rather than daily lab operations.

    Key Responsibilities

    Serve as CLIA Laboratory Director per 42 CFR §493.1405

    Provide regulatory oversight for moderate-complexity testing

    Review and approve:

    Quality Manual and SOPs

    QC, calibration, and maintenance records

    Training and competency documentation

    Oversee:

    Method verification before patient testing

    Proficiency Testing (PT) participation and review

    Quality assurance and corrective action activities

    Participate in periodic quality review meetings

    Support inspection and audit readiness

    Be available for consultation to clinic leadership and lab staff

    Qualifications

    Meets CLIA Laboratory Director requirements for moderate-complexity testing

    MD, DO, PhD, or qualifying doctoral degree

    Prior experience as CLIA Lab Director or Technical Consultant

    Working knowledge of CLIA regulations and laboratory quality systems

    Experience with physician-office or startup labs preferred

    Engagement Structure

    Independent contractor

    Remote oversight with periodic virtual meetings

    On-site availability for inspections if required

    How to Apply Submit CV and brief note outlining CLIA director experience.

    1. Laboratory Director – Scope of Services Outline

    Engagement Type: Independent Contractor Role: CLIA Laboratory Director – Moderate Complexity

    Scope of Oversight Services

    Regulatory Oversight

    Serve as designated CLIA Laboratory Director

    Ensure compliance with CLIA 42 CFR §493

    Provide guidance on state laboratory licensing requirements

    Documentation & Quality Systems

    Review and approve:

    Quality Manual

    Standard Operating Procedures

    Document control processes

    Establish QC and QA programs

    Review QC logs monthly or quarterly

    Personnel Oversight

    Approve training and competency assessments

    Provide guidance on personnel qualifications

    Testing Oversight

    Approve method verification protocols

    Review verification results before go-live

    Oversee Proficiency Testing participation and results

    Inspection Readiness

    Support preparation for CLIA inspections

    Participate in inspection responses if needed

    Consultative Support

    Provide reasonable availability for questions and guidance

    Compensation

    Monthly retainer: 1000–$1,500

    Term: 12 months, renewable

    Independent contractor relationship