Clinical Lab Scientist I

Perform high-complexity laboratory testing on clinical specimens and interpret/report results.

Support panel build and sample processing projects for Clinical Validation Studies.

Handle shipping, receiving, and internal testing of clinical samples in compliance with study protocols.

Document all activities in Case Report Forms, Trial Master Files, or electronic lab notebooks following Good Documentation Practices (GDP).

Ensure compliance with study protocols, IRB guidelines, ICH regulations, GCP, and related global regulatory standards.

Analyze and interpret experimental data using statistical and data analysis tools.

Monitor and evaluate quality control/test results against acceptance criteria to support study decisions.

Participate in clinical validation testing and maintain inspection-ready trial documents.

Support audits/inspections (FDA, regulatory, or internal) as required.

Troubleshoot laboratory instrumentation issues and participate in investigation or exploratory testing.

Communicate results, prepare reports, and present findings at internal meetings.

Collaborate cross-functionally with clinical operations, regulatory, and research teams.

Maintain laboratory safety standards (OSHA, ISO, QSR) and participate in lab maintenance and safety programs.

Clinical laboratory testing (high-complexity)

Molecular biology techniques (pipetting, assays, sample handling, cell culture)

Data analysis software (Excel, GraphPad, JMP, R, or equivalent)

Quality Control (QC) review and troubleshooting

Technical writing & documentation (Case Report Forms, Sample Accountability Logs)

Knowledge of GCP, GDP, ICH, IRB, and FDA regulatory guidelines

Laboratory safety and compliance (OSHA, ISO, QSR)

Instrument handling and troubleshooting

Bachelor’s degree in Biological Sciences, Life Sciences, Chemistry, Biochemistry, or a related field (required).

Master’s degree (MS) in Life Sciences or related field (preferred, but not mandatory).