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Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board. As a Research Support Assistant, Per Diem, you will provide clerical support to Clinical Research Associate, Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Research Manager.
$19.5 - $29.87 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.
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Work Performed Operations, Study and Site Management – 48% Effort Develop and submit Institutional Review Board [IRB] documents such as consent forms, protocols, and continuing reviews.
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Thorough understanding of federal regulations including U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), Department Health and Human Services (DHHS); International Conference on Harmonization Good Clinical Practices (ICH GCPs), and Institutional Review Board (IRB) policy.
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Trains coordinators on all Institutional Review Board-related activities such as submission, modifications, reporting, and termination activities. Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable.
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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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Assists in preparing grant applications and documents (e.g., Institutional Review Board, Grants, and Contracts Office), and provides clerical support to Clinical Research Coordinators and others in assigned areas.
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Prepare regulatory submissions, and ensure Institutional Review Board renewals are completed. We seek a Cancer Clinical Research Coordinator Associate -Blood and Marrow Transplantation & Cell Therapy (BMT-CT) to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach.
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Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH.
$61,242 - $86,121 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Educator and Trainer ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). In collaboration with the Associate Dean for Cancer Clinical Research and the Administrative Director of the Cancer Institute Clinical Trials Office, the Workforce Development Educator and Trainer supports the growth and development of the Penn State Clinical Trials Office (CTO) by achieving strategic objectives including overseeing multiple project activities related to training and education of clinical research staff and investigators.
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Supports regulatory staff submission of study protocols and amendments, consent forms, and recruiting materials to the Institutional Review Board and department for approval with oversight from supervisor.
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Prepares grant applications and documents and assists in protocol submissions (for e.g., Institutional Review Board, Grants and Contracts Office). Obtains informed consent under supervision of the Principal Investigator, Clinical Research Manager, or Senior Clinical Research Coordinator for studies enrolling vulnerable subjects, and for studies involving genetic tests.
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The Research Associate Clinical I-Data Manager will help the study team in preparing for monitoring visits and audits and ensure compliance with all federal and local agencies including the Food and Drug Administration ( FDA ) and local Institutional Review Board ( IRB.
$17.24 - $27.59 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Clinical, research, and/or personal experience working colorectal cancerFamiliar with Institutional Review board protocols, databases, etc. The project coordinator will manage and coordinate aspects of research as well as assist with participant payment, data analysis, manuscript preparation, completion of interviews, and IRB submissions.
$62,400 - $67,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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May maintain study and regulatory documentation including working with the Institutional Review Board (IRB), ensuring all staff involved in the study are trained and that the training is appropriately documented.
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