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Full Time Management OCT-Ohio Clinical Trials, Columbus, OH, US

3 days ago Requisition ID: 1355

About Company:

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life‑enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high‑need therapeutic areas in the U.S. and globally.

To support the continued growth of our Phase I business, ERG is building a new, stand‑alone CLIA‑certified and GLP‑compliant safety laboratory located within our state‑of‑the‑art Miami facility. This laboratory will be fully integrated with ERG’s early‑phase clinical operations and designed to provide high‑quality, timely safety testing to support first‑in‑human and other early‑phase clinical trials.

Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting‑edge research alongside industry leaders. We also offer competitive benefits including medical and dental coverage, a matching 401(k), and paid time off to recharge.

Job Description:

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.

• 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.

• 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).

• We foster innovative thinking, empowered decision‑making, and strong professional relationships. Learn more about us at www.ergclinical.com
• Evolution Research Group (ERG) is an equal opportunity employer and welcomes a diverse workforce.
• We are committed to fostering, cultivating & preserving a culture of Diversity, Equity & Inclusion.