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The Research Support Services (RSS) unit in SOM Deans Office / Finance Division works with SOM departments and units with its Pre-Award support needs, acting as the Pre-Award Contract and Grant Analyst for the department and PI, providing the coordination, preparation, budget development and routing of all SOM/RSS client department proposals for sponsored funding (except for industry initiated/funded clinical trials which are support by the Center for Clinical Research.
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Compliance Oversight for clinical trials; implement monitoring plans for UPenn and external study sites. The Clinical Research Coordinator B (Regulatory Coordinator) will play a critical role in ensuring research studies comply with relevant regulations and guidelines and will recruit and screen patients for clinical trials as needed.
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The Senior 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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Knowledge of MedDRA and WHODrug coding and experience overseeing coding and SAE reconciliation activities for clinical trials. In addition to the CDM and Biometrics teams, you will have the opportunity to be a part of the larger group of people under the CMO, which is comprised of Clinical Pharmacology, Development Operations, Drug Safety and Pharmacovigilance, Medical Affairs, R&D Medicine, and Regulatory.
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The Associate Director of Quantitative Science is a self-sufficient and high-impact position that focuses on supporting the statistical and data science needs in the risk-based monitoring (RBM) of clinical trials, serving in roles such as CSM lead (CSM: Centralized Statistical Monitoring), while also support other activities such as preclinical studies, biomarkers, application of AI/ML and development of analysis applications.
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Accountable for planning, design, execution, and results of the Clinical Affairs Biomarker team & clinical trials program. 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.
$185,500 - $235,500 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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Establish and manage relationships with external partners relevant to the design & implementation of clinical trials improvement/innovation projects for NACD & Novo Nordisk (e.g. Investigators and site staff, Health Systems, Contract Research Organizations and Site Management Organizations etc.
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During the one-year fellowship, the F.A.S.T. fellow will learn about clinical trial design, including novel clinical trials for rare genetic pediatric NDDs including N-of-1 trials, development of specialized programs for clinical management of these conditions with accommodation of experimental treatments, and new outcome measure and biomarker development for these populations.
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The School of Medicine (SOM) has a contract/grant portfolio of over $280M from Federal, State, non-profit and private Sponsors for basic and clinical research, clinical trials, training, and public service projects.
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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. This position is part of the Chemical Chemistry and Immunoassay (CCIA) Clinical Affairs department located in Chaska, Minnesota and can be remote.
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Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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Perform integrative analyses of multi-omics data from clinical trials and research cohorts, including genomics, transcriptomics, proteomics, and imaging, to identify biomarkers related to treatment mechanism and response, and potential therapeutic targets.
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Opportunities in quality improvement, research, and clinical trials exist locally within the Department and systemwide with our “sister” Children’s Hospital in Greenville through our Pediatric Service Line.
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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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Participates in planning current and long-term projects to improve the implementation of clinical trials in the MGH Cancer Center. The MGH Cancer Center Protocol Office Research Nurse Manager (CCPO RNM) is accountable for the facilitation of excellence in patient care when executing clinical research protocols.
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