About the role

  • 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).

Benefits

  • medical and dental coverage
  • a matching 401(k)
  • paid time off to recharge

Job title

Laboratory Manager

Job type

Experience level

Junior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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