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The CRC I incumbent presents study information at research staff meetings and ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB.
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Ensure facility compliance with applicable regulations, guidelines, and standards related to animal care and use (e.g., USDA, FDA, ISO, and AAALAC) Assist the Attending Veterinarian in managing the clinical care of animals in the vivarium as needed.
$125,000 - $140,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Educates and supervises staff to ensure compliance with applicable Inova SOPs, ISO, FDA and other Quality System Regulations, as well as applicable Environmental, Health & Safety, Human Resources and all other regulatory and administrative policies.
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Continuous Improvement: Identify and drive opportunities for process improvement within the Software Engineering function to enhance efficiency, quality, clarity, and compliance. The engineer will play a critical role in shaping the process for defining and documenting software-centric design control elements and deliverables, as well as the software development process itself, ensuring alignment with regulatory requirements such as FDA guidance, and meeting both user and business needs.
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Act as a resource for the research studies' regulatory activities including, but not limited to, interpreting, preparation, coordination, implementation and compliance with the Institutional Review Board (IRB) guidelines, FDA requirements, and Good Clinical Practice procedures.
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Ensuring compliance with ICH/GCP and applicable regulations, including the management through resolution (e.g. CAPA) of any site or study level issues, deviations, etc. · Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods.
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Train new CTO staff in all areas of IRB submissions and FDA compliance procedures. Prepare files for monitoring visits and internal external audits, including those by the Cancer Center CTO, Cancer Center DSMB, VA Compliance Office, commercial sponsors, National Cancer Institute, and its cooperative groups.
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Ensure donor suitability, product integrity, and continued good health of donors through the center’s compliance with Food and Drug Administration (FDA) regulations, state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards.
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The ideal candidate will have a strong background in clinical research, knowledge of ICH GCP, FDA CFR, FDA Bioresearch Monitoring Compliance programs, Health Canada regulations, EMA regulations, excellent communication and organizational skills, and the ability to navigate complex situations with professionalism and efficiency.
$137,041.3 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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The Clinical Safety Associate, Safety Operations will be responsible for the flawless execution of Safety and Pharmacovigilance operations, implementing Arrowhead’s safety reporting processes and ensuring compliance with FDA, international and global safety reporting requirements for all investigational clinical products.
$120,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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O Experience in software product development, including user needs assessment, software system analysis, architectural design, integration and testing, Reliability Engineering, Project Management, and Failure Modes Effects Analysis.
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Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc. Improving compliance through complaint and service signal tracking.
$163,300 a yearFull-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
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8+ years of experience in quality assurance, regulatory affairs, compliance roles, and EHS program management within the pharmaceutical or biotechnology industry, including expertise in FDA (GLP), USDA, AAALAC, OLAW, DEA, OSHA, and environmental health regulations.
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The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL.
$170,000 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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This position is responsible for managing the operations of the Post Market Compliance functions, such as Field Actions, Stability Testing, Adverse Event Reporting, Post-Market Surveillance, and Product Complaints.
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fda compliance jobs in San Diego, CA
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