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The Clinical Trials Regulatory Specialist will work within in multidisciplinary teams of highly skilled physicians, research scientists, cell manufacturing experts, and clinical research staff to conduct innovative early phase clinical trials according to Good Clinical Practice and all relevant institutional, state, and federal policies.
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Regulatory Coordinator Oncology Clinical Research Unit [CRU] GENITOURINARY Clinical Research Program [GU] Position Description, Occupational Summary Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] Genitourinary Clinical Research Program [TNA.
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Participate in efforts to provide outstanding clinical care, maintain/improve quality and patient safety, access to and management of clinical trials, and developing/refining innovative strategies in the field of adult cardiac surgery.
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The Clinical Research Coordinator III performs a full range of clinical research duties at an advanced level and plans, organizes, leads, and performs comprehensive clinical trial duties for multiple or complex clinical trials, focusing on the overall productivity and success of the program.
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The person will support Infectious Disease Physician Investigators in clinical research ranging from observational trials to investigational drug/product trials, including investigator-initiated, government funded, and industry-sponsored trials.
$42,953 - $77,315 a yearExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Oversee all EDC,and IRT vendor contracts for assigned clinical trials. Manage and maintain vendor budgets for assigned clinical trials and process flows and data exchanges with global pharmacovigilance for clinical trial serious adverse events.
Full-timeRemoteExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Today, our team continues to expand across the globe, with over 350 employees across the US, Europe, Australia, and Asia. The Role:Ora's Clinical Research Coordinator I (CRC) has close relationships with the subjects who participate in our clinical trials located regionally, domestically, and at times, internationally.
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Response Technology (IRT) vendors for assigned clinical trials. Oversee the production of all Data Sciences timelines and deliverables for assigned clinical trials and all DSS-related cross-functional meetings with clinical teams, safety teams and physicians.
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Performs gating, analyses and scientific review of high dimensional flow cytometry data collected from immuno-oncology clinical trials. Follows Navigate Flow Cytometry Subject Matter Expert (SME) guidance and training to deliver on fit-for-purpose analytical strategies that fulfill mechanistic endpoints of investigational clinical studies.
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We are a diverse team of experienced physicians and clinical scientists who collaborate to delineate early phase clinical development strategies, design innovative phase I-IIb clinical trials, develop and validate novel surrogate endpoints, and translate scientific ideas to proof of concept studies in targeted patient populations.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Early phase clinical/translational research expertise, including experience in designing, monitoring, performing and interpreting early phase clinical trials and solid knowledge of biomarkers, surrogate endpoints, biostatistics, and safety reporting.
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We are recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, FCS offers patients access to more clinical trials than any private oncology practice in Florida.
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The Brain Modulation Lab Project Manager is responsible for administrative management and support of all research projects and clinical trials conducted within the clinical and research practice of the Principal Investigator, Mark Richardson, MD, PhD, Director of Functional Neurosurgery.
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UHCMC and CWRU are research sites for the North American Mitochondrial Disease Consortium and the Urea Cycle Disorders Consortium as well as sites for several other industry-sponsored clinical trials and registries in a broad range of metabolic disorders (including OTC gene therapy and upcoming PKU gene therapy trials among other intervention focused trials.
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Preferably one of the following ASQ Certifications: CMQ/OE Certified Manager of Quality/Organizational Excellence, CQA Certified Quality Auditor, CQE Certified Quality Engineer, CRE Certified Reliability Engineer, CSSBB Certified Six Sigma Black Belt. Strong knowledge of regulatory requirements for cell and gene therapy products, ISO-7 cleanroom, and clinical trials is preferred ( eg.
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complex practice clinical trials jobs Company: Emory University
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