Assistant Lab Manager

Evolution Research Group•Miami, FL

13h•Onsite

About The Position

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. The Laboratory Manager will oversee laboratory personnel, workflows, quality systems, and compliance activities to ensure all laboratory operations meet CLIA, GLP, GCP, IRB, SOP, OSHA, and applicable state and local regulatory requirements.

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.
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).

Nice To Haves

additional experience strongly preferred

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.
Coordinate 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.