Primary Purpose:

Provides oversight of the Institute for Neuro-Immune Medicine's (INIM) clinical laboratory. This position is responsible for ensuring CLIA compliance, supporting clinical and translational research activities, overseeing laboratory operations and quality standards, and contributing to the Institute's educational and teaching mission.

Job Category: Exempt

Hiring Range: Commensurate with experience

Pay Basis: Annually

Subject to Grant Funding? No

Essential Job Functions:

1. Provides medical and administrative oversight of the clinical laboratory, ensuring compliance with all applicable federal, state, accreditation, and Clinical Laboratory Improvement Amendments (CLIA) regulations.
2. Directs and monitors day-to-day laboratory operations, including quality assurance, quality control, testing procedures, laboratory safety, and regulatory compliance activities.
3. Collaborates with faculty, researchers, clinicians, and laboratory personnel to support clinical, translational, and research initiatives within the Institute for Neuro-Immune Medicine (INIM).
4. Reviews, implements, and maintains laboratory policies, procedures, and protocols to ensure accurate, reliable, and compliant laboratory testing and operations.
5. Provides scientific and clinical expertise regarding laboratory testing methodologies, interpretation of results, and validation of new assays and technologies.
6. Supports research activities and grant-funded projects through consultation, study development, laboratory oversight, and regulatory compliance.
7. Monitors laboratory performance metrics and quality indicators and implement corrective actions as necessary to maintain operational excellence.
8. Promotes a culture of continuous improvement, safety, collaboration, and regulatory compliance within the laboratory and across the Institute.
9. Teaches and facilitates learning in related disciplines through lectures, laboratories, small-group instruction, and other educational activities.
10. Serves on department, college, and university committees and participate in faculty meetings and accreditation-related activities.
11. Participates in the development, implementation, assessment, and continuous improvement of curriculum and course content.
12. Displays professional behavior and ethics in all aspects of job performance.
13. Performs other duties as assigned or required.

Job Requirements:

Required Knowledge, Skills, & Abilities: Knowledge
1. Knowledge of Clinical Laboratory Improvement Amendments (CLIA), CAP, FDA, and other applicable regulatory and accreditation requirements governing clinical laboratory operations.
2. Knowledge of laboratory quality assurance, quality control, safety standards, proficiency testing, and continuous quality improvement processes.
3. Demonstrated expertise in laboratory testing methodologies, assay validation, data interpretation, and laboratory information management systems.
4. Knowledge of clinical and translational research principles, research compliance requirements, and grant-funded research activities.

Skills
1. Demonstrated teaching, mentoring, and curriculum development skills in support of academic and training programs.
2. Strong analytical, problem-solving, organizational, and decision-making skills.
3. Excellent verbal, written, and interpersonal communication skills, including the ability to present scientific and technical information to diverse audiences.
4. Ability to manage multiple priorities, meet deadlines, and work independently while maintaining a high level of accuracy and professionalism.
5. Proficiency in Microsoft Office applications and other laboratory-related software systems.

Abilities
1. Ability to provide leadership and oversight of laboratory personnel, operations, strategic initiatives, and regulatory compliance programs.
2. Ability to collaborate effectively with faculty, researchers, clinicians, students, and administrative stakeholders in a multidisciplinary academic environment.
3. Ability to develop, implement, and evaluate laboratory policies, procedures, and best practices.

Physical Requirements:
1. Speech Recognition - Must be able to identify and understand the speech of another person.
2. Speech Clarity - Must be able to speak clearly so others can understand you.
3. Near Vision - Must be able to see details at close range (within a few feet of the observer).
4. May be exposed to short, intermittent, and/or prolonged periods of sitting and/or standing in performance of job duties.
5. May be required to accomplish job duties using various types of equipment/supplies, to include but not limited to pens, pencils, mobile devices, and computer keyboards.

Required Certifications/Licensures:

Required Education: Terminal Degree (Ph.D.)

Major (if required: Clinical Laboratory Science, Pathology, Biomedical Sciences, Molecular Biology, Immunology or related field

Required Experience: 1. Five (5) years of experience in a clinical, research, or academic laboratory environment.
2. Demonstrated experience overseeing laboratory operations, quality assurance programs, regulatory compliance, and laboratory personnel.
3. Experience with CLIA, CAP, FDA, and/or other applicable regulatory and accreditation standards.

Preferred Qualifications:

1. Previous experience serving as a Clinical Laboratory Director or Associate Director.
2. Board certification in a relevant clinical laboratory specialty, where applicable.
3. Experience in neuro-immune, molecular diagnostics, immunology, or related biomedical research fields.

Is this a safety sensitive position? Yes

Background Screening Required? No

Pre-Employment Conditions: