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The Clinical Data Scientist position interacts with many FDA stakeholders across several Offices and Centers specifically with clinical reviewers (Medical Officers) and statistical reviewers.
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Clinical chemistry, immunoassay FDA & EU or Class III medical device experience with broad knowledge of medical device industry, regulatory requirements, and frameworks. Serve as primary clinical point of contact with the US FDA and other foreign regulators and notified bodies, and act as Clinical Lead for complex FDA negotiations leading to successful new product clearance and approvals for the Biomarker program.
$117Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The MGH PET Center is a cGMP registered Positron Emission Tomography (PET) radiopharmaceutical manufacturer which produces sterile injectable radioactive drug for diagnostic imaging procedures at MGH. We produce several different PET drugs for a variety of clinical and clinical research indications, including clinical diagnostic imaging of cancer with F-18 Fludeoxyglucose.
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The Clinical Affairs Director for Beckman Coulter Diagnostics is responsible for leading comprehensive global clinical trial strategies to support the complex Clinical Chemistry and Immunoassay Biomarker-Flywheel (Biomarker) program and for managing a multi-level team of clinical managers and clinical scientists/affairs associates.
$117ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The primary responsibility will be to interpret and report clinical cases in molecular diagnostics and assist the Division Director with assay design, feasibility studies, and clinical validation consistent with all regulatory guidelines (CAP, CLIA, FDA.
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This position is part of the Chemical Chemistry and Immunoassay (CCIA) Clinical Affairs department located in Chaska, Minnesota and can be remote. Accountable for planning, design, execution, and results of the Clinical Affairs Biomarker team & clinical trials program.
$117Full-timeExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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Or, ABMGG board certified/eligible for certification in Clinical Cytogenetics and Genomics. Or Clinical Molecular Genetics and Genomics. One (1) year of proven clinical laboratory experience in diagnostic review and reporting, molecular assay design, validation, and implementation compliant with CLIA and CAP guidelines.
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Comprehensive knowledge of ISO, GCP, ICH, FDA and other applicable regulations governing the conduct of clinical trials. The CRA II will be responsible for the study start up process for AtriCure’s Clinical Investigational protocols, which includes and is not limited to the following: protocol review, Informed Consent Development, CRF design, EDC testing, preparation of site-specific logs/documentation and investigator study files.
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Compliance Adherence: Ensure strict site adherence to regulatory requirements, including implementing SOP's, US FDA Good Laboratory Practices (GLP), and current Good Manufacturing Practices (cGMP) under preclinical to clinical grade testing.
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Clinical trial, Phase I-III, oncology, drug development, CRO, FDA, ICH Guidelines, GCP, TMF. This role is an opportunity for an experienced Clinical Operations Professional with technical expertise supporting Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP), and U.S. Food and Drug Administration (FDA) regulatory requirements.
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Participate in the I-SPY TRIALS, a ground-breaking national public-private collaboration among NCI, FDA, more than 20 cancer research centers, and major pharma, biotech companies as well as the University of California-wide Athena Breast Health Network, a learning system designed to integrate clinical care and research as it follows 150,000 women from screening through treatment and outcomes.
$250,000 - $360,000ExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Thorough understanding of federal regulations including U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), Department Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practices (ICH GCPs), and Institutional Review Board (IRB) policy.
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CTM, Clinical trial, Phase I-III, oncology, drug development, CRO, FDA, ICH Guidelines, GCP, TMF. Management of clinical studies and vendors to ensure studies are completed on time, within budget, and in compliance with Standard Operating Procedures (SOPs), FDA regulations, and International Council for Harmonization (ICH)/ GCP guidelines.
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The Director, Clinical, Preclinical, and Diagnostic Quality Assurance ensures GLP, GCP, CAP/CLIA compliance with ImmunityBio Standard Operating Procedures (SOPs), ICH guidelines and US FDA regulations, and Preclinical and Clinical study protocols/plans.
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This role will include activities prior to shipment as well as transactional entry activities aligned with US Customs, Census, FDA, USDA, FWS, CDC, and other Partner Government Agencies (PGA) requirements.
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