Lab Coordinator

Lab Coordinator

The role of a Lab Coordinator assists all team members of the clinical research team. The Lab Coordinator is responsible for ensuring all lab activities are completed timely, accurately, and per study protocol. This position includes but not limited to processing lab samples, shipping lab samples per protocol specification and timeline.

The Lab Coordinator reports to the Site Manager/Lab Manager.

Classification: Non-Exempt

Primary Responsibilities:

• Ensure compliance with regulatory and 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 and monitor requests assist with remote and on-site lab monitoring visits, including document retrieval, sample reconciliation, and audit preparation.
• Develop and 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 specimens 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 refrigerators 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 in a 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.

AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor.

** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.