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. Plus, we offer competitive benefits include 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.
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.
Skills and 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).
Join Our Team:
- 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.
Skills Required
- Bachelor of Science degree
- At least one year of experience in an early-phase clinical research laboratory
- Florida Supervisor License in all areas of testing performed, or ability to obtain it
- Working knowledge of CLIA, GLP, GCP, and clinical research laboratory operations
- Leadership and people-management skills
- Organizational, analytical, and problem-solving abilities
- Ability to manage multiple priorities in a fast-paced early-phase research environment
- Strong communication and collaboration skills
- Proficiency in Microsoft Office applications, including Word, Excel, and Outlook
- Additional experience in an early-phase clinical research laboratory
What We Do
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late stage neuroscience drug development. With 21 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. The ERG portfolio of sites we own consists of Woodland International Research Group, Woodland Research Northwest, Midwest Clinical Research, Pacific Research Network, Clinical Pharmacology of Miami, Brain Matters Research, Neuropsychiatric Research Center, Richmond Behavioral Associates, Finger Lakes Clinical Research, Endeavor Clinical Trials, and HD Research, all supported by an industry leading centralized infrastructure located in New Jersey. ERG offers consulting services to pharmaceutical and CRO clients, including access to key opinion leaders in Schizophrenia, Pain, Alzheimer’s disease, Sleep Disorders, Depression, Hepatic/Renal Impairment, Podiatry and Clinical Pharmacology. This includes Rater Training Services, Centralized Data Services (ECG, PSG, EEG, qEEG, Actigraphy), Medical Writing Services, Study Feasibility and Site Recommendation ERG also offers general consulting in study design, protocol review and budget planning, vendor resources, Scientific Advisory Board Planning and Implementation, study feasibility and site recommendations.
