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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. Summary 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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Works independently to prepare research-related protocols (pre-clinical, clinical, laboratory, and animal) for review by CRC/IRB/IACUC, including but not limited to initiation/submission/re-submission/termination utilizing PDOL and eResearch within institutional and departmental guidelines.
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Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572's and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.
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These include, but are not limited to, the following reviews and decision points: PEO Digital Program Decision Reviews, DON Chief Information Officer Clinger-Cohen Act (CCA) submissions, DON Gate Reviews / Portfolio Sufficiency Review, Investment Review Board (IRB), Milestones (MS)/ATP decision events with the Milestone Decision Authority (MDA.
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The AVP also oversees pre-award compliance and the Institutional Review Board (IRB), the Institutional Animal Care & Use Committee [IACUC], and the Unmanned Aircraft Systems Review Board (UASRB.
$9,167 - $29,425 a monthExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Clinical research, Oncology, inpatient, Gcp, Irb, Data management, BLS, CPR, AED, Registered Nurse, communication and leadership skills, CCRC or CCRP Certified, patient registration, quality assurance, subject eligibility, EMR, clinical trial, regulatory, oncology nursing, chart review, enrollment, adverse event reporting.
$30 - $45 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Maintains communication with the SRC (Scientific Review Committee) and IRB (Institutional Review Board): annual updates, adverse events, safety reports, protocol amendment, consent modifications.
$56.98 - $88.23 an hourExpandApply NowActive JobUpdated 10 days ago - UpvoteDownvoteShare Job
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The IRB Regulatory Consultant will oversee regulatory operations of studies conducted by one or more Disease and Modality Team within Montefiore Einstein Cancer Center, including, internal (investigator-initiated studies), Cooperative group, and industrial protocols (pharmaceutical and biotechnology company studies.
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Oversee and supervise operations related to federal research regulatory committees (IRB, IACUC, and IBC), conflict of interest, research integrity, responsible conduct of research, and export controls.
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The IRB Regulatory Consultant will work with investigators, study staff, local and Central Institutional Review Board, and the sponsor of the clinical trial to ensure that the studies are conducted in compliance with ICH GCP, the FDA, IRB, and other regulatory requirements.
$80,000Full-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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The fourth component involves contributing to research activities including data analysis (mostly qualitative and mixed methods) and supporting Dr. Miller's lab manager regarding data management needs, research reporting, and participant activities (e.g., preparing IRB submission materials, clinical trials materials, HSIP payment tracking.
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Understanding and working knowledge of principles of SOPs, GCP, FDA, IRB, clinical research methodology, regulations, and compliance required SKILLS/COMPETENCIES REQUIREDWorking knowledge of STATA is a must, as it is the CICL statistical software of choice.
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Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer.
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Maintain a line of communication with the Institutional Review Board IRB to keep abreast of new guidance related to protocol and informed consent submissions for initial reviews and amendments.
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Familiarity with clinical trials, IRB protocols, remote data capture (e.g., REDCap, Qualtrics), and database management preferred. Familiarity with clinical trials, IRB protocols, remote data capture (e.g., REDCap, Qualtrics), and database management preferred.
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