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.
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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
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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).
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hr@dawarconsulting.com
kavitha@dawarconsulting.com