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Assist Clinical Scientist, Study Responsible Scientist (SRS), &/or Study Responsible Physician (SRP) in various clinical research assigned Immunology Development clinical trials.
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The Laboratory Operations Manager (CLS Kitting) will utilize their expertise in central laboratory operations to oversee the execution of clinical trials kitting projects for multiple fast-paced clinical studies supporting clients engaged in cutting-edge research.
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Provide oversight of the global Quality Management Systems that support the quality functions of all critical operations including laboratories, supplier qualification, clinical trials, including commercial diagnostic products.
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The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
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Is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. We apply our expertise to trials at all stagesfrom early development through approvalwith embedded experience in oncology and rare disease.
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Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics.
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The product support specialist role works with the Business Operations group in the development and creation of electronic consent forms for clinical trials. The product support specialist role works with the Business Operations group in the development and creation of electronic consent forms for clinical trials.
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This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Arcus Standard Operating Procedures (SOPs) as appropriate.
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Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future product development strategic plans interacting with upper management of potential partner/acquisition companies during Due Diligence and alliance negotiations.
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PROGRAM DESCRIPTION The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.
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You will provide programming support to statisticians in production of summary tables, data listings and graphs required for clinical trials, and CDISC datasets for regulatory submission.
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With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
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Foster effective collaboration with cross-functional teams, such as IT, data management, and regulatory affairs, to ensure successful implementation of e-health trials. Collaborate in crafting clinical trial protocols, ensuring compliance with regulatory and ethical standards.
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The Clinical Research Monitor works in partnership with the AFT Project Manager and individual study teams to complete all site monitoring activities across assigned AFT projects and ensures all participating sites are compliant with Good Clinical Practice (GCP), SOPs, policies, and regulatory requirements throughout the life of assigned clinical trials.
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Supply Chain Maestro: Dive into the intricate world of supply chain management, overseeing the lifecycle of investigational products for clinical trials. As a Clinical Trial Drug Supply Specialist, you'll be at the forefront of ensuring the smooth operation of clinical trials by managing regulatory compliance and investigational product activities.
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clinical trials jobs in Frederick, MD
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