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The Regulatory Coordinator I will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, UCSD IRB, and the CTO. This position requires regular interaction with a variety of internal and external contacts including Cancer Center investigators and staff, UCSD IRB staff, study sponsors and/or their representatives.
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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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In partnership with Clinical Research, Medical Affairs and Development functions, ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialization of Gilead's products.
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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. Accountable for planning, design, execution, and results of the Clinical Affairs Biomarker team & clinical trials program.
$185,500 - $235,500 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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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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Perform as a key member on internal and external project teams and serve as the regulatory point of contact to facilitate CMC regulatory development as it relates to global clinical trials, global health authority interactions and global product submissions and approvals.
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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.
$43,919 - $56,349 a yearFull-timeExpandUpdated Today - UpvoteDownvoteShare Job
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Advanced degree in Science, Healthcare, or Regulatory/Clinical Affairs. Interact with R&D, Marketing, Regulatory, Medical and Scientific Affairs, and other global functions as well as senior leadership teams and global partners to apply advanced critical thinking to build strategic plans for new biomarker development, stakeholder management, and technology dissemination such as Real-World Evidence, ensuring benefit from the new capabilities and opportunities these enable.
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Manages and coordinates all facets of assigned clinical protocols from IRB preparation through query and data seal; ensuring protocol and regulatory compliance. The Ivy Brain Tumor Center is a non-conventional, non-profit program offering state-of-the-art clinical trials for patients with the most aggressive form of brain cancer.
$30.55 - $44.3 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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A minimum of 9 years’ experience in the design, planning and conduct of GCP clinical trials; with at least 5 of those most recent years working as an employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO.
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Legal Support of the Global R&D operations in the Americas and overseas: contract drafting, negotiation and counsel on clinical trial agreements, informed consent and clinical trials associated matters including privacy, transparency, regulatory compliance, regulatory inspection and pharmacovigilance.
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Skills: Ability to interpret, analyze, and present clinical data Thorough understanding of the drug development process Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization.
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Preferably one of the following ASQ Certifications: CMQ/OE Certified Manager of Quality/Organizational Excellence, CQA Certified Quality Auditor, CQE Certified Quality Engineer, CRE Certified Reliability Engineer, CSSBB Certified Six Sigma Black Belt. Strong knowledge of regulatory requirements for cell and gene therapy products, ISO-7 cleanroom, and clinical trials is preferred ( eg.
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The Brain Modulation Lab is involved with several major NIH and industry-sponsored clinical trials and the Project Manager will support multiple active protocols, serve in the capacity of lead Clinical Research Coordinator of trial teams, maintain regulatory documentation, Standard Operating Procedures, and train staff members to ensure compliance.
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You would support the delivery of GMP clinical material to support clinical trials, while collaboratively developing the appropriate control strategies to support regulatory submission, transfer of process technology to manufacturing sites to enable product commercialization.
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