Laboratory Manager
Evolution Research Group
full-time
Posted on:
Location Type: Office
Location: Miami • Florida • United States
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Job Level
Tech Stack
About the role
- 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).
Benefits
- medical and dental coverage
- a matching 401(k)
- paid time off to recharge
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
laboratory operationsquality controlquality assuranceSOP developmentdata reportingsample processinginventory controlassay validationelectronic data transferperformance management
Soft Skills
organizational abilitiesanalytical skillsproblem-solving skillstime managementleadershipcommunicationmentoringcoordinationmulti-taskingattention to detail
Certifications
Bachelor of Science degreeState of Florida Supervisor License