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The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study.
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Regulatory Coordinator Oncology Clinical Research Unit [CRU] Brain TUMOR CLINICAL Research Program [BTC] Position Description, Occupational Summary Perform regulatory and safety processes for multiple, complex oncology clinical trials and research studies including Investigational Products [IP] for the Duke Cancer Institute’s [DCI] TEAM Clinical Research Program [BTC.
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Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
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Preferred: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) is preferred. Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification, along with a minimum of two years additional professional experience, will be considered in place of degree.
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In addition to the responsibilities above, the Clinical Research Coordinator B will assist the regulatory specialist in preparing for all local and Central Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, modifications, and adverse event reporting.
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Extensive knowledge of regulatory standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management and records management (e.g. DIA TMF reference model) Minimum of 10 years of working in clinical research and drug development in the pharmaceutical industry (and/or Contract Research Organizations) with specific experience with TMF, clinical documentation and/or records & information management.
$205,000 - $260,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Certified Clinical Research Associate (CCRA) credentialing. In collaboration with clinical trial teams across the country, will support the clinical trial research goals of the CTCC by monitoring numerous centers specified trial cycle metrics and protocol fidelity, and oversee local, institutional and federally-required regulatory compliance across the network of collaborators.
$55,200 - $96,600 a year depends on experienceFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Licenses and Certifications Preferred: Certified Clinical Research Professional (CCRP) and/or Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC.
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Participates and gives lectures in weekly resident seminar series on ACLAM boards material Regulatory responsibilities:Serves on the IACUC as an alternate member. Trains at off site primate clinical rotations at Charles River and Bastrop primate facilities.
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The Clinical Research Resources Office (CRRO) Regulatory Education Manager will manage two important aspects of the HRPP: the Research Professionals Network (RPN) and the human/clinical research education and training for Boston University and Boston Medical Center researchers (PIs and study staff.
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The ACC CRU is currently comprised of 12 Research Teams that support disease/discipline specific cancer programs within the ACC. This Program Manager will have oversight of the ACC CRU-Leukemia Research Team. Job Description The Program Manager position will directly report to the Physician Leader of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU)- Leukemia Research Team and indirectly report to the ACC CRU Associate Director Research Operations.
$61,046 - $95,524 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Lead the execution of global CMC regulatory plans, including overseeing the submission and approval process in close partnership with other functions in Research and Development, Regulatory Affairs, and Clinical Development.
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The Clinical Research Coordinator is also responsible for keeping all data and source documentation, adverse event reporting, and IRB regulatory files. The primary responsibility of the Clinical Research Coordinator is to coordinate and conduct the day-to-day operation of clinical studies and clinical trials related to maternal health and diabetes.
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The Associate Principal Scientist will work closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and correctly executed to support the product strategy.
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The Sue and Ralph Stern Center for Cancer Clinical Trials and Research (Stern Center) within the CFCCC provides centralized services for protocol review and monitoring, regulatory affairs, study management, coordination with internal and external partners on study financial terms and arrangements, and oversees accounts receivable, financial projections and reporting on clinical studies.
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regulatory operations clinical research associate jobs Company: Eteam
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