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Clinic Research Coordinator II The Clinical Research Coordinator II , will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor.
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Working understanding of GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices. Lead the following data management activities for multiple clinical development programs: Database transfer, CRF development, Database specifications, User acceptance testing, Query resolution, Data review, Database lock.
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Understanding and working knowledge of principles of SOPs, GCP, FDA, IRB, clinical research methodology, regulations, and compliance required. The CICL provides echocardiography core laboratory services for primarily large-scale global clinical trials responsible for site training and interface as well as echo analysis of images received.
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Specifically, responsible for study start-up activities and regulatory management of industry sponsored, FDA regulated clinical trials. Clinical research experience required, especially with FDA regulated clinical trials and IRB submissions.
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Using available systems and tools, the Clinical Research Associate will monitor and oversee site activities both onsite and remotely to ensure that patients’ rights, safety and well-being are protected and that the data generated at sites are complete and accurate.
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Works under the supervision of the Section Chief, the direction of the Chief of Pathology and Clinical Laboratories and the Director of Operations. Complies with accrediting agencies (FDA, CAP, DNV, AHCA, CMS , AABB) standards and regulations.
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Maintain and organize records of protocol versions, FDA and IRB submission dates, and FDA & IRB approval dates. Familiarity and experience with NIH clinical trial policies from an oversight perspective.
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Interact with FDA and other regulatory authorities to ensure clinical studies meet regulatory requirements and to ensure ongoing agreement on project development. Support the Regulatory head in interacting with FDA and other regulatory authorities to ensure clinical studies meet regulatory requirements and to ensure ongoing agreement on project development.
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Maintaining GLP compliance for all laboratory work and documentation related to biospecimen data management and sample handling in accordance with FDA regulations and company SOPs. Assisting in maintaining GLP compliance in the laboratory.
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Years Experience in Validating GxP applications Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality Support Risk assessment Document Regulatory Requirements and Review Specification documentation (viz.
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Learn and maintain thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures.
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Complete, organize and maintains all documentation required by the Food and Drug Administration (FDA) Code of Federal Regulations (CFR), Good Clinical Practice (GCP) Guidelines, or the funding source.
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The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research. Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
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Execute quality oversight of manufacturing clinical and US commercial finished goods assembly/packaging/labeling up through lot disposition to include review and approval of Deviations, Change Controls, CAPAs.
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This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) for assigned products. Independently leads cross functional teams through all labeling discussions with the FDA/CHMP while ensuring management alignment.
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