Lab Supervisor

About the role

The Assistant Laboratory Manager, Clinical Research (CLIA/GLP) is responsible for assisting operational leadership and direction for ERG’s clinical safety laboratory. This position will play a key role in the build-out, launch, and ongoing operation of a new stand-alone laboratory supporting Phase I clinical studies.

Responsibilities

• Assist with the build-out, start-up, and day-to-day operation of a CLIA-certified and GLP-compliant clinical research safety laboratory.
• Assist Lab Manager with the directing and coordinating 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.
• Manage laboratory testing menus, including evaluation of new assays, validation planning, and coordination with reference laboratories when appropriate.
• Serve as a backup point of contact for sponsors and internal clinical teams, including participation in study initiation meetings.
• Cook up sample processing, storage, and shipment in accordance with protocol and sponsor requirements.
• Oversee laboratory supply management, inventory control, and equipment maintenance.
• Ensure accurate and timely electronic data transfers and laboratory data reporting to sponsors when required.
• Maintain a safe, organized, and inspection-ready laboratory environment.

Qualifications

• 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.
• Demonstrated leadership and people-management skills.
• Excellent organizational, analytical, and problem-solving abilities.
• Ability to manage multiple priorities in a fast-paced early-phase research environment.
• Strong communication skills with the ability to collaborate effectively with internal and external stakeholders.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook).