Our client, a world leader in Pharmaceuticals and In-Vitro Diagnostics (IVD) tools, is seeking a "Clinical Lab Scientist I" for Tucson, AZ

Responsibilities

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

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

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

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

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

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

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

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

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

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

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

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

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

Skills

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  Clinical laboratory testing (high-complexity)

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

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

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  Quality Control (QC) review and troubleshooting

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

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

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  Laboratory safety and compliance (OSHA, ISO, QSR)

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  Instrument handling and troubleshooting

Education

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

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