Laboratory Manager overseeing clinical safety laboratory operations for early-phase clinical trials at ERG. Responsible for compliance, quality assurance, and laboratory personnel management.
Responsibilities
Lead the build-out, start-up, and day-to-day operation of a CLIA-certified and GLP-compliant clinical research safety laboratory.
Direct and coordinate laboratory personnel to ensure quality, accuracy, and timeliness of laboratory testing and reporting.
Ensure compliance with CLIA, GLP, GCP, IRB requirements, SOPs, OSHA standards, and applicable regulatory requirements at all times.
Support CLIA and accreditation readiness activities, including inspections, audits, and corrective actions as needed.
Oversee quality control, quality assurance, and proficiency testing programs.
Develop, write, implement, and maintain laboratory SOPs, procedure manuals, and quality documentation.
Manage laboratory testing menus, including evaluation of new assays, validation planning, and coordination with reference laboratories when appropriate.
Serve as a key laboratory point of contact for sponsors and internal clinical teams, including participation in study initiation meetings.
Coordinate sample processing, storage, and shipment in accordance with protocol and sponsor requirements.
Oversee laboratory supply management, inventory control, and equipment maintenance.
Manage, mentor, and evaluate laboratory staff, including performance management and timekeeping as applicable.
Ensure accurate and timely electronic data transfers and laboratory data reporting to sponsors when required.
Maintain a safe, organized, and inspection-ready laboratory environment.
Requirements
Bachelor of Science degree required.
Minimum of one (1) year of experience in an early-phase clinical research laboratory; additional experience strongly preferred.
State of Florida Supervisor License in all areas of testing performed, or ability to obtain.
Strong working knowledge of CLIA, GLP, GCP, and clinical research laboratory operations.
Excellent organizational, analytical, and problem-solving abilities.
Ability to manage multiple priorities in a fast-paced early-phase research environment.
Proficiency in Microsoft Office applications (Word, Excel, Outlook).
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