-Responsible for the daily operation of the lab: staffing, workflow, quality, safety and regulatory compliance.
-The position is responsible for providing daily management and strategic direction for the laboratories.
-Ensures compliance with all relevant regulatory agencies including FACT, JC, OSHA, and CLIA.
Does this position require Patient Care? No
Essential Functions
-Develops and maintains QA systems to ensure high level of performance and effective remedial actions to address deviations from performance specifications.
-Assigns, monitors and supervises work to ensure compliance with laboratory SOPs and applicable federal, state and regulating agencies requirements including health/safety and patient confidentiality.
-Ensures the laboratory is prepared for all regulatory reviews and inspections including Joint Commission and FACT.
-Oversees coordination of clinical trials with principal investigators, study coordinators, quality assurance and compliance.
-Conducts interviews and recommends candidates for hiring according to department policies to ensure adequate staffing for the laboratory.
-Responsible for staff training and education including required department training (safety, infection control, compliance)
Education
Bachelor's Degree Laboratory Sciences required
Can this role accept experience in lieu of a degree?
No
Licenses and Credentials
Medical Technologist (ASCP) - American Society for Clinical Pathology Board of Certification (ASCP-BOC) preferred Histotechnician/Histology Technician [HT(ASCP)] - American Society for Clinical Pathology Board of Certification (ASCP-BOC) preferred
Experience
Lab experience 5-7 years required and Demonstrated leadership experience in hospital-based CLIA laboratory 3-5 years required
Knowledge, Skills and Abilities
- Detailed knowledge of all regulatory requirements including FACT, Joint Commission and CLIA.
- Expert knowledge of laboratory health and safety protocols.
- Effective written and verbal communication skills.
- Strong knowledge of personnel and employment practices.
- Ability to effectively manage staffing levels and workloads.
- Ability to effectively interview and train new employees.
Physical Requirements
Clinical Manager Blood Bank Laboratory • Newton, MA, United States