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Experience in clinical research, familiarity with oncology protocols, clinical trials operations, GCP, NCI guidelines and federal regulations both FDA and HHS. Experience 2-5 Years' experience as a Clinical Research Associate, Clinical Research Coordinator, Clinical Research Nurse Coordinator and proven experience as an Lead Auditor.
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In depth knowledge of regulations and guidance supporting GCP and GLP to include FDA, EMA, ISO standards and ICH guidelines with direct impact to clinical programs. Experience working effectively with CROs/CSPs. Expe rience with electronic Quality Management Systems and Trial Master File. Skills and Abilities A solid understanding of GCP, GLP, GMPs and CMC requirements is expected.
$155,000 - $190,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH.
$61,242 - $86,121 a yearExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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The Research Coordinator will develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations and Food and Drug Administration (FDA) regulations.
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In executing these responsibilities, the Rater is guided by FDA regulations, Good Clinical Practice (GCP), relevant workplace practices, and company standard operating procedures. Requirements Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
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Knowledge of GLP and GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules, including drafting, interpreting, and implementing quality assurance policies and procedures for regulatory documents, as well as establishing document management activities.
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Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Comply with Actym Therapeutics SOPs and adhere to ICH, GCP, and relevant regulatory guidelines. A minimum of 10 years of experience in clinical development within the biotechnology or pharmaceutical industry; previous experience in immuno-oncology drug development is preferred.
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Facilitates all audits of study with staff of JFK Medical Center, sponsor, FDA, and other regulatory agencies. Mandatory education on human subject research and GCP (CITI Training and Certification.
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Strong knowledge of ICH/GCP/FDA regulations, with at least 2 years of Site monitoring/CRA experience required. Ensures study adherence to ICH/GCP/FDA regulations and SOPs. The CTM will be responsible for partnering with internal and external business functions and vendors throughout the study's life cycle in accordance with company SOPs, ICH/GCP, and all applicable local regulations.
$77Full-timeExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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Knowledge of FDA regulations and GCP-ICH guidelines; and comprehensive understanding of clinical trials processes and the conduct of clinical research studies. This candidate must also have a thorough knowledge of Federal Regulations and ICH-GCP guidelines, and a comprehensive understanding of clinical trial processes, and the conduct of clinical studies.
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Collaborate with Quality teams to ensure compliance with regulatory standards, including but not limited to GMP, GLP, and GCP, as applicable. Act as Official Correspondent to Regulatory Authorities (e.g., FDA) on behalf of Cresilon, Inc. Submit Marketing Applications to Regulatory Authorities on behalf of Cresilon, Inc. Represent Cresilon, Inc to Regulatory Authorities, both in writing and in person.
$160,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.) 10+ years’ experience in Good Manufacturing Practice (GMP) / QA within Food and Drug Administration (FDA) regulated environments.
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Experience in preparation and participating in inspections by the FDA is and/or other accrediting audits as may be required for GLP or GCP compliant laboratories. Conduct inspections and internal audits in accordance with GCP, GLP and GCLP guidelines to ensure corrective actions are addressed in a timely fashion.
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Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements. Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization.
Full-timeRemoteExpandApply NowActive JobUpdated 3 months ago - UpvoteDownvoteShare Job
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The VP, Quality will have end-to-end Quality responsibilities inclusive of leading GLP, GCP, GVP and GMP functions. Collaborates with internal functions and aligns goals and objectives for pre-clinical to commercial phase programs and products, ensuring cGMP, GCP, GVP and GLP compliance and realization of other value-added guidelines and best practices.
$315,000 - $320,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago
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