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Clinical Research Lab Technician

Job Summary
The Clinical Lab Technician is responsible for the collection, processing, handling, and shipment of biological specimens in accordance with study protocols, Good Clinical Practice (GCP), and laboratory standards. This role ensures accuracy, compliance, and timely execution of all lab-related study procedures.

Responsibilities

Specimen Collection & Processing
Perform blood draws (venipuncture), urine collection, and other protocol-required specimen.

Lab Compliance & Documentation

Follow study-specific lab manuals and protocol requirements
Accurately document all lab procedures in source documents
Ensure proper labeling (subject ID, visit, date/time, initials)
Maintain chain of custody for all specimens
Assist with eCRF/lab data entry when applicable

Sample Storage & Shipment

Store specimens under correct conditions (ambient, refrigerated, frozen)
Maintain and monitor temperature logs (e.g., LogTag reports)
Prepare and ship samples to central labs per IATA guidelines
Track shipments and resolve discrepancies

Equipment & Inventory Management

Maintain lab equipment (centrifuges, freezers, refrigerators)
Ensure calibration and maintenance logs are up to date
Monitor lab supplies and kit inventory
Report any equipment malfunctions immediately

Quality Control & Audit Readiness

Ensure all lab activities meet GCP and regulatory standards
Participate in monitoring visits, audits, and inspections
Maintain organized lab binders and documentation
Identify and report protocol deviations or lab issues

Safety & Infection Control

Follow OSHA and biosafety guidelines
Use proper PPE at all times
Handle biohazard materials appropriately
Maintain a clean and compliant lab environmentRequirements
Process samples (centrifugation, aliquoting, labeling) per protocol/lab manual
Ensure proper timing of collections (critical for study endpoints)
Maintain specimen integrity at all times
Bachelor’s degree or higher in biological sciences, veterinary technology, or related field; relevant experience may substitute educational requirements.
Proven experience working in an industrial or clinical laboratory environment with a strong understanding of GLP standards.
Knowledge of FDA regulations, CGMP (Current Good Manufacturing Practice), and quality control processes.
Familiarity with laboratory techniques including microbiology, histology, molecular biology methods, and analysis skills.
Experience with Laboratory Information Management Systems (LIMS) for data collection and reporting.
Strong understanding of laboratory procedures, safety protocols, and research & development practices.
Excellent math skills for data analysis and interpretation; ability to follow detailed protocols precisely.
Ability to work efficiently both independently and as part of a multidisciplinary team within a fast-paced setting. Join us in advancing scientific research through meticulous laboratory work that makes a real difference!

Qualifications