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The Center for Cancer Cell Therapy (CCT) at Stanford University is seeking a Clinical Trials Regulatory Specialist 2 to be responsible for the administration and regulatory compliance of clinical research within the university and representing the university with external regulatory agencies, both domestic and international.
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SCI - Clinical Trials Regulatory Specialist 2 (Hybrid) Clinical Trials Regulatory Specialist 2 - Center for Cancer Cell Therapy (Hybrid) 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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Serves as the Records Manager for all clinical trials at Corcept throughout the TMF lifecycle (i.e., from study start up to archiving) Working directly with the respective study teams, oversees execution of study TMF plans, ensuring all clinical study documentation is collected, handled, transferred, stored and/or entered into Corcepts Veeva Vault TMF in compliance with SOPs and global and local standards and requirements.
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Partner with Clinical Development, Regulatory, Pharmacovigilance, Quality Assurance, Commercial organizations on design and execution of clinical trials in Corcept portfolio. Stay current with regulatory requirements for statistical methods of analyses and scientific developments in statistical methods for clinical trials.
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You will provide programming support to statisticians in production of summary tables, data listings and graphs required for clinical trials, and CDISC datasets for regulatory submission.
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Providing support in production of summary tables, data listings and graphs required for trial report and clinical development, and CDISC data sets for regulatory submission. Develop SAS code and table templates for preparing, processing, and analyzing clinical data.
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In addition to treating patients with chemotherapy or on clinical trials, the team manages acute medical problems such as neutropenic fever, pulmonary embolism/DVT, spinal cord compression, hypercalcemia, nausea and vomiting, pain management, palliative care, biliary obstruction, bowel obstruction, pleural and pericardial effusions, pneumonia, atrial fibrillation, and other acute medical diagnoses.
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Experience in all aspects of protocol conduct, both early and late phases, including protocol writing, start-up, study execution, analysis, and reporting Sufficient content expertise to be able to meaningfully contribute to document development and data review and interpretation under the direction and oversight of the CMO. Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and clinical trials guidelines is required.
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Lead biomarker and pharmacokinetic planning, definition, and implementation, overseeing sample collection for early and late-phase clinical trials. Extensive oncology experience, including proficiency in target/disease biology, preclinical, and clinical development.
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Full-service oncology care with multi-modality treatment, clinical trials, nurse navigation, survivorship, outpatient infusion, and a five-time recipient of the ACoS Outstanding Achievement Award.
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Through experience gained from over 19,000 clinical trials delivered in support of 870 regulatory approvals, Clario fuses scientific expertise and global scale into the broadest endpoint technology platform to enable pharmaceutical, biotech and medical device partners to transform lives.
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Seeking a Research Nurse 2, and will be under the direction of the principal investigator and/or research nurse manager, applying medical knowledge and experience to oversee and direct clinical course of research participants in clinical trials.
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Ensure scientific integrity and data quality of clinical trials are preserved. We are seeking an experienced, high caliber Senior Biostatistician to join Abbott’s medical device clinical research organization.
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Work closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, nonclinical) to facilitate the execution of clinical trials and ensure high standards of study conduct are met.
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Perform simple lab procedures per study requirements (blood pressure, calculation of body mass index); Assist Principal Investigator in compiling summary data from trials; Perform literature searches and retrieve needed information from retrieved articles; Help prepare supplemental materials and text for manuscripts, publications, and grants.
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clinical trials jobs in Sunnyvale, CA
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