Clinical Lab Manager
BioCytics
Company Description
BioCytics Inc is located in Huntersville, NC. BioCytics was founded by Dr. John Powderly, MD, a board-certified oncologist and president of Carolina BioOncology Institute (CBOI).
Role Description
This is a full-time on-site role as a Clinical Lab Manager at BioCytics Inc in Huntersville, NC. As a Clinical Lab Manager, you will be responsible for overseeing the day-to-day operations of our clinical lab. This includes managing sample collection, processing, and analysis, ensuring compliance with research protocols and CLIA/COLA regulations, maintaining laboratory equipment, supervising lab staff and hands-on routine testing. You will work closely with the research team, including scientists and physicians, to support ongoing clinical trials and contribute to the development of personalized oncology treatments.
Qualifications
- Bachelor's degree or higher in clinical laboratory sciences, chemistry, biology, immunology or equivalent
- Certification as a Medical Laboratory Scientist (or equivalent) by a nationally recognized board/agency (ASCP, AAB, AMT).
- At least four (4) years of working experience as a Medical Technologist in a full-service high-complexity clinical laboratory. At least 1 year of flow cytometry and immunology experience. Supervisory experience preferred.
- Previous experience in a clinical laboratory setting, preferably in oncology research or related field
- Strong knowledge of laboratory techniques and procedures, including clinical chemistry, hematology, immunology and flow cytometry
- Experience with quality assurance and quality control practices in a laboratory setting
- Experience with laboratory inspections, and full understanding of CLIA regulations
- Familiarity with regulatory requirements and compliance standards for clinical research (e.g., IRB, FDA)
- Excellent organizational, communication, and leadership skills
- Ability to work effectively in a team and collaborate with cross-functional stakeholders
- Attention to detail and ability to manage multiple tasks and deadlines
- Proficiency in relevant computer software and data management systems
Job Summary
This position reports directly to the Clinical Laboratory Director. The Laboratory Manager is responsible for the daily operations, administration, technical supervision and management of human and financial resources of the clinical laboratory including flow cytometry. This is a working manager position including routinely performing hands-on laboratory testing.
Ensures compliance with COLA/CLIA, CMS, HIPAA, FDA and other regulatory agencies and laws governing laboratory services. Ensures implementation and administration of department quality program. Directs, supports, and promotes continuous improvement of quality and services.
Skills and Abilities
Demonstrated competency in high-complexity clinical laboratory skills including but not limited to quality control, proficiency testing, automated testing systems, hematology manual differential, urine microscopy, immunology assays, flow cytometry, general chemistry and molecular diagnostic testing. Ability to adapt to accreditation/regulatory changes in the laboratory industry. Ability to analyze data, draw conclusions and interpret results. Ability to communicate effectively, both orally and in writing. Ability to demonstrate responsibility, dependability, and professionalism. Ability to maintain inventory control systems and make budgetary projections. Ability to organize, prioritize, multi-task, and adapt to changing priorities. Ability to provide excellent customer service. Ensures laboratory coverage on a day-to-day basis. Ability to solve problems and identify solutions. Ability to train, orient, and evaluate the job performance of new employees and students. Ability to work effectively with individuals at all levels of the organization. Physical and other Requirements Occasional light lifting is expected. Ability to sit/stand for extensive periods of time. Key skills include supervision, coaching, prioritization and management of multiple tasks, good written and oral communication, record keeping, time management, self-motivation/drive, excellence, efficiency, productivity and teambuilding. Establish and maintain effective working relationships with coworkers, managers and clients.