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This position is to work with our world renowned Pediatric Stem Cell Transplant team as an Advanced Practice Provider on our in-patient unit at LPCH. Our team offers unique treatments not available elsewhere, including clinical trials testing gene therapy for blood diseases like sickle cell disease and pyruvate kinase deficiency, and a first-in-the-world treatment that combines kidney and stem cell transplantation to give patients a new kidney that will last without long-term immune suppression.
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Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials. The Lead Clinical Research Associate (LCRA) is responsible for managing the development, coordination and implementation of site management and clinical monitoring responsibilities for clinical studies with guidance from the Clinical Trial Manager.
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Weve developed a proprietary AI-guided antibody discovery platform as a solid foundation for innovative biologics with diverse formats (e.g. mAb, bispecific antibody and fusion proteins), and other diverse modalities such as ADC, mRNA, and CART. Well-funded and supported by our unique research, development, and clinical validation ecosystem under our corporate umbrella, the team encompasses industry veterans with proven track records of bringing novel biologics to global clinical trials.
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The ideal candidate will have a background in clinical trials, data capturing, and working with wearables, devices, or VR products. Apex Systems is seeking a Clinical Research Coordinator to support data collection in the lab.
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Manage and deliver technical program for the fermentation pilot plant to support field trials at customer’s sites, process scale up, new market development and production of mems. Significant travel to domestic and international locations might be required to support field trials.
$280,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Synthego’s mission is to enable agile life science research and development from discovery through clinical trials by providing scientists with comprehensive CRISPR solutions for each phase coupled with full technical and regulatory support from industry-leading experts.
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We connect patients with clinical trials, help clinicians order our test and receive our clinical reports, and deliver valuable genomic datasets to researchers to help uncover important insights into treatment paradigms and drug discovery.
$196,800 a yearFull-timeRemoteExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials.
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Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. Understands drug development phases and the nature of associated clinical trials across phases.
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By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to the microbial landscape to accelerate biomarker discovery and clinical trials, discover novel microbes, to ultimately reduce patient suffering worldwide.
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Under the direction of the Executive Director, Clinical Operations, this role will support and manage several aspects of one or more AAV gene therapy clinical trials, including engagement and direct oversight of the clinical centers, investigators, study coordinators, and clinical CROs. The role is responsible for actively contributing to the development and implementation of the strategies and timelines needed to achieve targets and goals, as well as managing the clinical budget.
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Reports To : Vice President, Engineering. B.S. or M.S. in Computer Science, Electrical Engineering, Physics, Statistics, Biomedical Engineering, Genetics, or a related engineering or science field. Hands-on experience with cloud-native software development and operations approach; primarily using tools and technologies such as Docker, Kubernetes, and Cloud services to run software services and data analytics jobs.
$290,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Understanding of the dynamics and challenges of the medical device market, such as reimbursement strategies, clinical trials, and FDA/EU MDR regulations. Understanding of the dynamics and challenges of the medical device market, such as reimbursement strategies, clinical trials, and FDA/EU MDR regulations.
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Has a thorough understanding of clinical trials design and reporting process, as well as regulatory reporting requirements including electronic data submissions. Job Description Sr Manager, Statistical Programming Key Skills:Successfully interacts within Clinical Data Science, with Clinical Development and Regulatory Affairs groups on a frequent basis.
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Preferred experience in Medical Affairs and/or Clinical Research including Phase IIIb and IV studies; clinical trials management, medical monitoring and scientific expertise. Serve as Medical Affairs therapeutic area expert on Global Publications and Scientific Message Platform committees and other support for Scientific Communications.
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trials job Title: wound in San Carlos, CA
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