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Ensures a robust framework for the quality oversight, review and approval of Quality Management System (QMS) standards and procedures for regulated activities in Clinical Research (GCP), Pharmacovigilance (GVP) and Medical.
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The CRC B (Regulatory Coordinator) will assist with preparing and processing regulatory documents through the IRB and other research review boards and have the ability to handle a variety of clinical trial related regulatory responsibilities in accordance with University of Pennsylvania, GCP, ICF, and FDA guidelines.
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Under the supervision of the Biospecimen Lab Manager, the Senior Biospecimen Coordinator supports the clinical research efforts of the Chao Family Comprehensive Cancer Center (CFCCC) by providing comprehensive coordination and data management of specimen correlative trials according to current Good Clinical Practices (GCP), Good Laboratory Practices (GLP), internal standard operating procedures (SOPs) and University policies and procedures.
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Basic knowledge of Industry Sponsored Clinical Trails, FDA, IRB Regulations, ICH guidelines and Good Clinical Practice (GCP)Basic knowledge of research data collection and storage procedures.
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The Clinical Research Coordinator II Non-RN (CRC II Non-RN) serves the AdventHealth Research Institute (AHRI) in the Rocky Mountain Region (RMR). + Certified Clinical Research Coordinator (CCRC) (per the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA.
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Animal handling, Animal husbandry, Animal science, Animal health, Animal research, Clinical research, Clinical trial, Gcp, Ekg, Crf, Crc, Patient recruitment, Epic, Clinical study.
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The Code of Federal Regulation (CFR), Good Clinical Practice (GCP) guidelines, and National Institutes of Health (NIH) research rules set standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials.
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Minimum 7 years of early clinical research and drug development experience, experience in translational and precision medicine research and biomarker sciences. Teva's R&D Global Early Clinical Development is hiring for a Senior Translational & Precision Medicine Leader (STPML) - Immunology in the Translational and Precision Medicine (TPM) group who will be accountable for the development and implementation of the overarching TPM strategy and deployment of innovative research approaches to enhance the probability of success of drug asset programs in the Immunology therapeutic areas (TA.
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DaVita Clinical Research (DCR) is a Renal Research site network conducting clinical trials across the country. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network.
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The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations, and SOPs. Key Responsibilities In collaboration with other members of the clinical research site team works to ensure the execution of assigned studies.
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This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Standard Operating Procedures (SOPs) as appropriate.
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Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
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Assist with initiation, implementation and management of research projects in accordance with GCP, FDA, HIPAA & all required regulatory guidelines, with an emphasis on pediatric clinical research studies.
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Experience with cancer-related research Current nationally-recognized clinical research coordinator certification (e.g. Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), etc.
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Experience with clinical research and data collection. Experience working in a clinical and/or research laboratory environment. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
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