JOB DESCRIPTION

Biorg has developed personalized oncological tests to be performed under CLIA certification. The company is seeking qualified candidates for the position of CLIA Director, with relevant training and experience to oversee non-waved complex clinical testing.​

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RESPONSIBILITIES

• Overseeing CLIA compliance

• Overseeing and reviewing efficacy testing results

• Reviewing SOPs, procedural updates, QC, and corrective actions

• Reviewing and approving established ranges, specimen requirements for tests, and acceptance criteria

• Reviewing all written policies and lab procedures.

• Remaining accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed

• Ensuring that the laboratory remains compliant with all applicable federal, state, and local regulations

 

EDUCATION / EXPERIENCE / QUALIFICATION

• MD or PhD in relevant fields

• At least 2 years of experience directing or supervising high complex clinical testing

• Current board certification by an HHS-approved board

• Current or previous role as CLIA director is preferred​