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Responsible for receiving, inspecting, accessioning, archiving, retrieving, labelling, packaging and shipping of clinical human biological samples and maintain LIMS records. Complies with applicable standards and best practices, such as CLIA, CAP, GCP, GLP, GDPR, HIPAA, Common Rule, HTA, etc.
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Maintain SOPs for review and approval by Capability Area Manager and monitors compliance with DoD/Army safety procedures and Good Laboratory Practice (GLP), Clinical Laboratory Improvement Amendments (CLIA), Clinical Laboratory Improvement Program (CLIP), and the College of American Pathologist (CAP) regulations.
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Serve as the subject matter expert on cross-functional teams to lead projects, direct GLP bioanalytical validations and sample analysis across all nonclinical, DMPK and clinical pharmacology development.
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The Director, Clinical Quality Assurance works directly with the Cardurion Quality Team, Translational Medicine, Cardurion K.K., Clinical Development, Clinical Operations, Regulatory Affairs, and the corresponding quality assurance staff members from the various CROs, clinical study sites, and clinical service providers to ensure effective execution of the Cardurion Quality System requirements and compliance with the applicable GLP, GCP, and GPvP guidelines, regulations, and industry standards.
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Develop clear preclinical trial strategies, design and write non-GLP and GLP study protocols, monitor, document, and interpret clinical study data. Stay current with GLP and regulatory requirements to support preclinical submission regulatory submissions including INDs. Interface with clinical development leadership to ensure preclinical activities are aligned with long term project goals.
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Laboratory work should be conducted in accordance with GLP, the Institute Animal Care and Use Committee (IACUC), and the American Association for Laboratory Animal Science (AALAS) Laboratory work should be conducted in accordance with GLP, the Institute Animal Care and Use Committee (IACUC), and the American Association for Laboratory Animal Science (AALAS.
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Previous experience of Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP). Support the identification of GCP, GCLP, GLP, and GVP (as pertaining to conduct of clinical trials) compliance risk areas (internal and external) and support the resolution, development, and implementation of risk mitigation measures.
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The RII operates a complete cGMP/GLP production facility to produce PET radiopharmaceuticals for human clinical and translational research. The PET Radiochemist is responsible for the daily production and quality control of routine PET radiopharmaceuticals for clinical and research studies.
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Function independently as a study director in the direction and execution of assigned studies in compliance with GLP or other applicable regulations for the conduct of nonclinical and clinical research.
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Responsible for translational aspects of the strategy and development of the Organon WH product portfolio, in line with Good Laboratory Practices (GLP), Good Clinical Practice (GCP) and relevant Organon Standard Operating Procedures (SOPs.
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SOP QA review, client hosting, regulatory agency hosting and external test site/clinical site/bioanalytical laboratory qualifications. Interprets GCP, GLP, and GCLP and associated regulatory documents to facilitate auditing and process improvement recommendations.
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Demonstrated technical and scientific knowledge of pharmacokinetics, pharmacometrics, formulation development and biopharmaceutics, bioanalytical method development and validation and clinical pharmacology a discipline to facilitate clinical development of drug candidates or in the assessment of business development opportunities.
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Demonstrates a thorough knowledge of Good Clinical Practice GCP , Good Pharmacovigilance Practices GVP , Good Laboratory Practice GLP , Good Documentation Practice GDP and ICH E6 R2 compliance requirements.
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Design and manage in vivo studies at CROs, GLP toxicity studies and assist in planning clinical studies. Strong hands-on experience in designing and executing in vitro and in vivo studies to validate targets and treatment ideas using ADCs, mAbs, or other targeted therapies.
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Assist in the execution of GCLP/GLP clinical and non-clinical study sample preservation and processing, staining and analysis using a variety of assay formats such as Histochemical special stains, Immunofluorescence and Immunohistochemistry.
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