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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. 5 Years' experience in clinical trials auditing.
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The coordinator will work on 10-15 clinical trials primarily within sickle cell disease. 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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The Clinical Research Coordinator (CRC) is central to conducting and managing clinical trials, tasked with obtaining informed consent, executing study protocols, handling human specimens, and ensuring meticulous documentation and communication.
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The Clinical Research Associate may be regionally based and is responsible for the monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs, to support New Drug Applications.
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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. The Rater is responsible for the organization, administration, management, and efficient execution of clinical ratings associated with clinical trials.
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Under the supervision of the Clinical Research Program Manager, the Clinical Research RN ensures the integrity and quality of clinical trials are conducted and maintained in accordance with federal, state, and local regulations, Institutional Review Board ("IRB") approvals, and Healthcare System policies and procedures.
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Define and manage phase appropriate QA activities in support of preclinical studies and clinical trials. Ability to assess R&D, non-clinical, and clinical documents for compliance to regulatory standards for GLP or GCP and to identify areas of non-compliance.
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Looking for an experienced Clinical Research Coordinator in the Kendall area of Miami! Preferably 2+ years of experience as a Clinical Research Coordinator. Their sites conduct Phase I-IV trials in therapeutic areas like cardiology, metabolic disorders, renal, CNS, pulmonology, women's health, and vaccines.
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Assists investigator with consent process assuring patients understand clinical trials. Knowledge of clinical trials and the regulation (local, state, and federal) of such.
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Desired and Required Qualifications Education and Experience: Bachelor's Degree in a life-science-based subject At least 3-4 years of trial coordination experience in a clinical research environment, with at least some within the biotech/pharmaceutical industry Basic understanding of drug development Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
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Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
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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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Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements. Experience with developing study concepts for clinical development and clinical trial designs with cross functional input, including biostatistics, observational research and patient reported outcomes in Phase 1,2 and/or 3 clinical trials.
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Demonstrated ability to gain understanding of the federal and institutional regulations and policies governing clinical research involving protection of human subjects (JCAHO, FDA, GCP, OHRP, IRB NIH/NCRR for PCRC only.
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In particular this will include developing and maintaining a deep knowledge of Good Clinical Practice (GCP) with respect to digital data management (i.e. use of novel technology within clinical trials.
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