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Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
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Ensures that departments/areas comply with or exceed all regulatory requirements including, but not limited to JCAHO, CDPH, CAP, OSHA, FDA.Manages the cancer DSL Network quality staff across all outpatient and inpatient departments, including BMT/CTF, radiation oncology, infusion services, cancer clinics, integrated clinical research, and Surgical Oncology; works with the operational and clinical research leaders to ensure all quality goals are met.
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Cultivate engagements between Danaher and biopharma key opinion leaders (KOLs) in hematology and related disease areas; possess in depth knowledge of biopharma drug pipelines in hematology and anticipate the diagnostic needs of pharma (from Research Use Only (RUO) to Clinical Trial Assay (CTA) to In Vitro Diagnostics (IVD) inclusive of Companion Diagnostics (CDx) and Lab Developed Tests (LDTs.
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Facilitates development of clinical strategy and trial design by interacting with study PIs, key opinion leaders (KOLs) and collaborating cross functionally with other departments including Global Clinical Operations, Research & Development, Regulatory Affairs, and Biostatistics.
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We research, develop, and commercialize innovative digital health products and solutions by bringing together the full capabilities of our team, including product strategy and management, clinical expertise, partnerships, UI/UX design, usability research, clinical research and validation, software development, AI / Gen AI, and regulatory submissions.
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Job DescriptionPrimary Function of Position:Comparative Medicine focuses on animal welfare, employee safety and efficiency to enable an internal clinical environment for use by the research and development and training organizations.
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We specialize in developing Samsung’s upcoming software-based medical devices and health services, including product definition and strategy, partner integrations, UI/UX design, usability research, clinical validation, regulatory submissions, and software development/lifecycle.
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We seek a Clinical Research Coordinator 2 – Radiology to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education, and outreach.
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The Clinical Research Associate will be responsible for practicing a standardized cognitive behavioral intervention as part of a federally-funded study of nonpharmacological treatment for headache attributable to mild traumatic brain injury.
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The Director, Clinical Operations (TMF, CTMS) is a clinical research drug development expert accountable for leading and optimizing the delivery of our next generation, integrated platform for clinical trial operations and document management systems including the people, process, technology that support these functions.
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Obtains regulatory documentation for successful implementation, monitoring and evaluation of clinical trials. - Contribute to development of annual operational budget for clinical research.
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Advice on legal issues throughout the medical device lifecycle related to clinical research, market access and reimbursement, product launches, commercialization, advertising and promotion, social media, patient access and financial assistance programs.
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One of the Top Hospital in California Teaching hospital Research driven institution Secure retirement Named among best places to work The Mechanical Circulatory Support (MCS) Coordinator is responsible for coordinating the clinical, procedural, administrative and educational care of inpatients and outpatients with end stage cardiac and pulmonary failure patients requiring mechanical circulatory support under the supervision of the Cardiothoracic Surgery and Heart Failure faculty and MCS manager.
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The Clinical Research Operations Specialist II will be responsible for the management of virtual and multisite operations by ensuring adequate study start up, regulatory submissions and training of each of the study sites in preparation for site activation.
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NCH is transforming into an Advanced Community Healthcare System(TM) and we’re proud to: Provide higher acuity care and Centers of Excellence; Offer Graduate Medical Education and fellowships; Have endowed chairs; Conduct research and participate in national clinical trials; and partner with other health market leaders, like Hospital for Special Surgery, Encompass, and ProScan.
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clinical research regulatory jobs in Sunnyvale, CA
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