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Incumbent will be responsible for the preparation and submission of study documents to the Institutional Review Board (IRB), and other regulatory committees. Experience working with IRB, IACUC and ICTS. Knowledge of OnCore, Epic, and EDC Systems (iMedidata, Medrio, Datatrack), IWRS systems, Kuali Systems.
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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.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Desired: 1) Human subjects research experience including knowledge of IRB, NIH, HIPAA and other regulatory rules and requirements, 2) Experience collecting Magnetic Resonance Imaging (MRI) data from human subjects, 3) Proficiency with Microsoft Office programs.
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The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, interacting with sponsoring agencies and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
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Ensure that the study, consent, and other documents provided to the subjects are approved by the Institutional Review Board (IRB) and comply with Good Clinical Practice (GCP) and other regulatory requirements.
$57 - $75 an hourFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Provide accurate patient cost descriptions for the Informed Consent Form (ICF) to be submitted to the Institutional Review Board (IRB). Responsibilities:Review New Study routing forms and essential study start-up documents.
$30 - $36 an hourTemporaryExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Main responsibilities include, but are not limited to, the review of New Study routing forms and essential study start-up documents, the itemized cost analysis and interpretation of clinical protocols into budgets milestones, provide accurate patient cost descriptions for the ICF to be submitted to the IRB, and update budget, milestones, and ICF information as necessary per contract/protocol amendments.
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The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, 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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Ensure that the study, consent, and other documents provided to the subjects are approved by the IRB and comply with GCP and other regulatory requirements. Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities.
Up to $350,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process.
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In this role, the applicant will be responsible for contacting various hospital departments to identify potential brain donors, address inclusion/exclusion criteria for the study, be on site to approach donors or families of donors when required, and to arrange brain donation with the UCI MIND brain tissue repository team.
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