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The role oversees and manages the Development QA team and interacts cross-functionally with functional teams who interact with and/or support Preclinical and Clinical Trials, which include Preclinical and Clinical Operations; and, Product Development, GMP teams, Pharmacovigilance, Medical Writing, Biostatistics and Data Management to ensures compliance to the Quality Management System (QMS) and all applicable regulatory requirements.
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Thorough knowledge of the clinical drug development process and experience in all aspects of global drug safety reporting from Clinical trials to Post Marketing. Knowledge of Pharmacovigilance regulations and guidelines including Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH.
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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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Knowledge of world-wide pharmaceutical and regulatory requirements, including GCP, ICH, and other Guidance documents and policies related to clinical trials required by FDA, EMEA, WHO and equivalent international regulations.
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Under the direction of the Chief Administrative Officer, the Clinical Research Coordinator (CRC) will be responsible for supporting the clinical research efforts of the Department of Urology by providing comprehensive coordination and data management of sponsored clinical trials according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.
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The University of Alabama at Birmingham (UAB), O'Neal Comprehensive Cancer Center is seeking a Manager-Clinical Research Coordination to provide oversight and management for the day-to-day efforts of the Cancer Center Clinical Trials Office focused cancer research coordination in conducting study activities including complex protocols in accordance with the protocol, IRB regulations, and Good Clinical Practice (GCP.
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Excellent understanding of the business processes, GCP standards and software used in clinical trials, outcomes research and real-world evidence generation. We are seeking an exceptional Senior Principal Statistician with strong statistical and computational skills to support multiple complex clinical trials in Oncology and COVID. The Senior Principal Statistician is responsible for leading and performing biostatistics and statistical programming activities in these trials, which may be Phase I, II and III pharmaceutical trials and medical device trials evaluating new biomarkers and/or therapeutics.
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Under supervision of the Clinical Research Manager of the Clinical Trials Unit, the Clinical Research Coordinator supports the clinical research efforts of the Cancer Center by providing comprehensive coordination and data management of multiple Phase I-IV cancer-related protocols according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.
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This role is an opportunity for an experienced Clinical Operations Professional with technical expertise supporting Phase I-III clinical trials in an industry setting and a strong knowledge of clinical operations, Good Clinical Practice (GCP), and U.S. Food and Drug Administration (FDA) regulatory requirements.
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QLHC is a pioneer that designs, implements, and succeeds at building and iterating creative and nimble solutions that drive meaningful results for patients through adaptive platform clinical trials, OneSource, and clinical trial matching.
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Experience with outsourcing and working with external academic and CRO partners to develop/transfer assays, oversee data generation/analysis and delivery of high-quality data from global clinical trials under regulated settings (GLP, GCP, GCLP and CAP/CLIA etc.
$143,500 - $205,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP, In Vitro Diagnostic Regulation (IVDR) 2017/746, General Data Protection Regulation (GDPR) and clinical laboratory specimen handling.
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Job Req ID: 112971 Clinical Research Monitor The Department of Neurology is seeking a who will take the lead on compliance monitoring of predominantly large, multi-centered, clinical trials in keeping with established BIOS Clinical Trials Coordinating Center (CTCC) policies and procedures and GCP. The CRM will ensure quality, accuracy and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials through utilization of a risk-based, remote monitoring approach.
$55,200 - $96,600 a year depends on experienceFull-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
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Demonstrated knowledge of ICH GCP, global regulations, and guidelines applicable for the conduct of clinical trials demonstrated knowledge of pharmacovigilance strongly preferred.
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R&D Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP is strongly preferred. TS has a broad remit stretching from support of discovery with human data to support target selection, through development of novel decision- making biomarkers for early phase clinical trials, target-centric indication sequencing and prioritization, and biomarker support of regulatory filings.
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