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The ideal candidate will execute, manage, and coordinate research protocols, data collection and operations of several concurrent clinical research studies under the guidelines of research protocols, UCSF/SFVAHCS and regulating agency policies.
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Working with Clinical Research team and key personnel including the Executive VP of Clinical Research, this highly skilled and team-oriented Medical Director will be a physician and will have subspecialty training in Nephrology or Infectious Disease or Rheumatology and have at least 1.5 years of clinical research and development experience.
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The Epstein Lab Director will be a research leader within the Department of Otolaryngology-Head and Neck Surgery and as such will work cooperatively with the clinical Division of Otology/Neurotology which is led by Dr. Charles Limb. Mentorship of medical students, residents, post-doctoral students, and clinical and research faculty is integral to the position.
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Our QSP & PBPK team has established expertise, impact, and tools, and we are looking for a highly motivated scientist to develop and apply Quantitative Systems Pharmacology (QSP) models with a primary focus on hematology, oncology, and cell therapy applications to primarily impact clinical development.
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You will also contribute significantly to our research and clinical development efforts as a core member of our research governance committees, and function as a core team member of our CSO Leadership Team and CSO Strategy Team to provide scientific input for translational and clinical biomarker strategy of all our pipelines.
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OCTA services improve compliance and enable a more rapid activation of clinical trials to increase and improve patient care and provide cutting edge treatment opportunities for our patients and advance our research mission.
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We have multiple ongoing research studies leveraging our proprietary real-world data, including an even larger ketamine analysis leveraging machine learning to predict treatment outcomes.
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Excellent understanding of the business processes, GCP standards and software used in clinical trials, outcomes research and real-world evidence generation. The trials also involve real world evidence generation, patient reported outcomes (PROs) and analysis of complex big data sets.
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The Clinical Data Research Consultants group’s services include the administration of Data Use Agreements for the reuse of CMS and Medicaid data, customized data extractions from UCSF health systems, a federated data steward program to support compliance and set best practice standards for analysts who access health system data outside of Central IT.
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Minimum of 10 years of working in clinical research and drug development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience with TMF, clinical documentation and/or records & information management.
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Nola Hylton, PhD (Professor, Department of Radiology and Biomedical Imaging, Director, Breast Imaging Research Program, University of California, San Francisco) Knowledge in breast imaging acquisition methods (MRI, mammography, ultrasound and/or PET) and clinical trials is highly desirable.
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Understanding of the related disciplines (i.e. biostatistics, regulatory, pharmacology and toxicology research, cell therapy manufacturing, clinical pharmacology and pharmaceutical sciences.
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Quantitative Systems Pharmacology (QSP) & Physiologically Based Pharmacokinetics (PBPK) have become important components of discovery and clinical development. + Desire to interact as a modeling and simulation expert with matrix project teams and working closely with experts from different functional areas (pre-clinical and clinical and multiple therapeutic areas.
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The UCSF Clinical Cancer Genomics Lab runs targeted gene sequencing, microsatellite instability testing, fluorescence in situ hybridization (FISH), and a 500+ gene next-generation sequencing panel for advanced diagnostic and prognostic molecular testing in patients with cancer.
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Has advanced knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field. As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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clinical research outcomes jobs Company: Pfizer in Brisbane, CA
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