Compliance Manager - James Labs (HS)

Scope of Position
Under the guidance of the Cytogenetics Technical Director and the James Laboratory Operations Director, this position is based in the Cytogenetics Lab and ensures activities are in compliance with all accreditations, regulatory, amp; licensing requirements.
The Compliance Manager will be the primary contact for Clinical Trials protocols, subject matter expert for the Cytogenetics Beaker application, support laboratory test development, test validations, billing practices and other compliance related tasks. The Compliance Manager acts as a representative for the organization when interacting with professional organizations, affiliated hospital systems and accreditation agencies related to policies and standards of compliance related to operations, billing, and lab information systems. This position will oversee the compliance program related to laboratory developed testing protocols, validations, and provide education for various clinical teams.

Position Summary
The Compliance Manager is responsible for compliance and staff education related audit tools for validations, laboratory developed testing protocols, pre-authorization of testing, billing practices, IHIS applications, adherence to Clinical Trials protocols, and other compliance related tasks. The Compliance Manager will review Clinical Trial protocols, provide required testing documentation, and communicate results to clinical research coordinators to determine patient eligibility and stratification. This position will serve as a subject matter expert for Beaker assay test builds, functionality, design requirements for enhancements as relates to compliance and reporting. The Compliance Manager will assist with labs preparation for accreditation surveys, review survey readiness activities, and serve as a representative for the organization as deemed appropriate.

Minimum Qualifications
Bachelors degree in Medical Technology or Biological Science with CG, MT, or MP (ASCP) certification with 5 years of genetics experience or at least 10+ years of equivalent job experience required. Prior experience with assay validation, SOP preparation for high complexity testing, and outstanding verbal and written communication skills desired. Previous experience with accreditation agencies / compliance programs preferred.

Career Roadmap:

FUNCTION: Clinical Labs

SUB-FUNCTION: Lab Compliance

CAREER BAND: Individual Contributor - Specialized

CAREER LEVEL: S3