The Clinical Laboratory Co-Director works directly with our current Lab Director and is responsible for managing overall laboratory operations for renegade.bio as directed and delegated by the CEO. The Clinical Laboratory Co-Director implements the clinical directives and works under the direct supervision of the CEO and in collaboration with the Clinical Laboratory Technical and General Supervisors. Ensures compliance with local, state, and federal requirements. Implements and maintains clinical practice standards and staff development. Provides oversight and consultant responsibilities in addition to performance responsibilities for molecular tests performed within the renegade.bio clinical laboratory.
Essential Duties and Responsibilities
The essential functions include, but are not limited to the following:
- Responsible for the overall management of the CLIA laboratory including administrative, financial, compliance, quality improvement, technical, and personnel activities in accordance with established policies and standards.
- Develop, implement, perform and maintain clinical laboratory molecular service tests.
- Provide molecular laboratory technical support to all levels of laboratory staff, management and administration to ensure the best methods of operation, testing, reporting and quality are understood and followed at all levels.
- Manage molecular laboratory staff and ensure the highest levels of quality requirements are met.
- Collaborate with the Technical and General Supervisors in developing, implementing, and maintaining clinical and pathology molecular laboratory service standards.
- Identify and implement opportunities to improve department systems.
- Monitor workflow and turnaround time throughout the molecular laboratory services of renegade.bio.
- Meet with Clinical Laboratory Technical and General Supervisors as necessary to ensure compliance and coordination with laboratory administration and overall laboratory management.
- Develop and monitor quality control and quality assurance programs for molecular laboratory.
- Identify and correct problems that may adversely affect test performance or reporting of patient samples.
- Ensure specimen evaluations for molecular testing are accurate, thorough, and in compliance with accreditation requirements.
- Identify and implement procedures to improve the accuracy of laboratory evaluations.
- Provide medical molecular laboratory diagnostic and therapeutic information, products, and services by establishing specimen preparation procedures; developing and implementing analytical procedures; evaluating laboratory information; consulting with pathologist(s); reporting results according to protocols mandated by the regulatory agencies and the public health department.
- Maintain molecular laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance; certifying instrument performance; arranging equipment replacement, service, and repair.
- Maintain and/or oversee medical molecular laboratory supplies inventory by monitoring inventory level; providing loss prevention and ensuring stock orders are sufficient for the testing needed.
- Maintain medical molecular laboratory productivity by monitoring workload of functional areas; identifying peak and slack periods; making operational or staffing adjustments.
- Maintain quality molecular results by maintaining a quality assurance system; consulting with pathologist(s); performing proficiency surveys; reviewing quality control and quality assurance programs; making adjustments in policy and procedures; generating reports; maintaining records.
- Ensure an efficient and functional medical molecular laboratory information system by identifying information needs and problems; recommending improvements; establishing priorities; testing; writing user manuals; training employees; maintaining security and confidentiality.
- Implement new programs, tests, methods, instrumentation, and procedures by investigating alternatives; preparing proposals; developing and performing parallel testing; monitoring progress.
- Maintain medical molecular laboratory staff by supporting the General Supervisor in recruiting, selecting, orienting, and training department employees.
- Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; and participating in professional societies.
- Comply with state and professional continuing education licensure requirements by providing in-service and/or educational programs; monitoring outcomes.
- Resolve problems by consulting with R&D, laboratory managers, technical supervisor,lab employees and other renegade team members,
- Ensure effective communication between laboratory staff, laboratory management, clinic management, and administration through meetings, lab visits or laboratory review.
- Perform the duties of Molecular Lab Director as defined by CLIA regulations for high complexity molecular laboratory.
- Takes on special projects or other assignments and completes them within a time frame.
- Meet and consult with renegade.bio CEO and Founders for policies, procedures, forms, instrumentation, equipment, supplies, and LIS.
- Promotes standardization throughout the laboratory system.
Minimum Qualifications (Knowledge, Skills, and Education)
- Knowledge of principles and techniques of clinical and pathology molecular laboratory testing procedures (i.e. DNA/RNA extraction, DNA/RNA library preparation; NGS, Target amplification, Quantitative PCR/rtPCR, and other molecular techniques).
- Knowledge of human genetics, NGS, and genotyping.
- Knowledge of medical terminology, communicable diseases, and environmental health issues.
- Knowledge of laboratory regulations, including quality control of media, reagents, and equipment, laboratory safety, laboratory documentation requirements, sterilization requirements, and laboratory equipment.
- Knowledge of applicable testing techniques.
- Knowledge of planning, budgeting, quality control, customer service, and supervision.
- 4+ yrs. experience in a clinical laboratory setting
- Experience with genetics or molecular biology techniques including DNA and RNA library preparation, Target amplification, and Next Generation Sequencing (NGS).
- Prior experience with CLIA/CAP laboratory is required.
- Knowledge of HIPAA and laboratory SOPs, regulatory and safety procedures.
- Attention to detail and accuracy are crucial for the position.
- Ability to work independently and also in a collaborative environment.
- Ability to multitask and prioritize laboratory and data analysis tasks.
- Strong interpersonal skills and the ability to successfully complete projects.
- Expertise in CLIA (federal) regulatory guidelines for LDT submissions.
- State specific regulatory standards and accreditation organization standards to include CAP/CLIA
- Skill in performing molecular laboratory tests (i.e. DNA/RNA extraction, DNA/RNA library preparation; NGS, Target amplification, Quantitative PCR/rtPCR, and other molecular techniques).
- Skill in project planning, laboratory operations, and budgetary control.
- Skill in using computers for database management, testing, and record-keeping functions.
- Experience as a laboratory supervisor, manager or technical consultant desired.
- Ability to communicate appropriately, both orally and written.
- Ability to collaborate effectively with the healthcare team.
- Ability to recognize and resolve hazardous conditions.
Education & Experience:
- MD, or PhD in a high complexity molecular laboratory science and have a minimum of one year of lab training or experience in the specialty of non-waived testing.
- Minimum of 5 years’ experience in a high complexity laboratory and two years supervisor experience in a high complexity and CAP certified laboratory.
- A valid CA High complexity Laboratory Director License (HCLD) from ABB.
- Knowledge of CAP, CLIA, and other local, state, federal regulations.
- Molecular Biology, MB (ASCP)
- CA Medical Laboratory Director License Or HCLD from ABB.
- Additional related Degrees/Certifications preferred.
Flexible schedule, 5 days/wk, some weekends needed
Job Type: FT
Benefits: Health, Vision, and Dental
120 hours PTO