CLIA Director

BIORG, INC.; Winston-Salem (NC); Hybrid; USD 70,000 - 110,000; Part time

Job summary

BIORG, INC. is seeking a CLIA Director to oversee non-waved complex clinical testing in a part-time capacity. The role involves reviewing efficacy testing results, SOPs, QC, and policies, with accessibility for onsite, telephone, or electronic consultation.

The position requires an MD or PhD and current board certification by an HHS-approved board. The ideal candidate has at least 2 years of leadership in high complexity clinical testing and is familiar with CLIA regulations and lab operations

Qualifications

• 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.
• CLIA director experience is preferred.

Responsibilities

• Overseeing and reviewing efficacy testing results
• Reviewing SOPs, procedural updates, QC, and corrective actions
• Reviewing 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

MD or PhD in relevant fields

Current board certification by an HHS-approved board

Job description

Location: Remote and Winston-Salem, North Carolina, United States

Employment Type: Part-Time

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.

RESPONSIBILITIES

• 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