Lab Coordinator

The Lab Coordinator reports to the Site Manager/Lab Manager. Classification: Non-Exempt

Primary Responsibilities

• Ensure Compliance with Regulatory & Safety Standards – Adhere to Good Clinical Laboratory Practices (GCLP), ICH-GCP, FDA, IATA, and OSHA regulations when handling and processing specimens.
• Perform Quality Control Checks – Regularly inspect sample processing, storage conditions, and lab documentation to ensure compliance and prevent deviations.
• Troubleshoot Lab Processing Issues – Identify and resolve sample processing delays, equipment malfunctions, and protocol deviations to prevent disruptions.
• Support Sponsor & Monitor Requests – Assist with remote and on-site lab monitoring visits, including document retrieval, sample reconciliation, and audit preparation.
• Develop & Implement Lab Training Programs – Train new team members on lab protocols, safety measures, and compliance requirements.
• Collaborate with Study Teams to Optimize Workflows – Work with monitors, clinical staff, CRCs, and regulatory teams to improve lab processes and efficiency.
• Draw labs and collect specimen per the study protocol
• Process and store lab specimens per study protocol
• Package lab specimens according to study protocol.
• Ship lab specimens per study protocol
• Answer queries in a timely manner
• Inventory lab supplies
• Unpack and put away supplies and study materials received from study sponsors.
• Maintain logs for refrigerator and freezers
• Maintain logs for required equipment
• Ensure calibration is maintained on all equipment
• Complete forms and study documents with accuracy
• Clean and sanitize lab area daily
• Remove subject identifying documents when assisting with remote monitoring activities.
• Assist clinical team with all study activities as needed. Such as vitals, EKG’s, phlebotomy, etc.
• Maintain a safe work environment, meeting IATA and OSHA standards.
• Serve as a resource in lab for all team members to ensure protocols are followed.
• Position may require occasional weekend and/or overtime hours.
• Other duties as assigned

Desired Skills and Qualifications

• Medical Laboratory Technology degree preferred
• Phlebotomy experience required
• Lab processing experience required
• College graduate preferred
• Ability to troubleshoot lab equipment malfunctions and implement corrective actions.
• Familiarity with hazardous material handling and biosafety protocols.
• Excellent attention to detail, organizational skills, and ability to manage multiple priorities.
• Ability to function independently with little oversight
• Professional, highly motivated self-starter, and exercises initiative.
• Collaborative with a team mentality
• Ability to work fast-paced environment
• Organization and prioritization skills
• Excellent follow-up
• Ability to be ambulatory most of the workday.
• Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination.
• Fluent in English.