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Independently manage regulatory submissions to the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), Office of Clinical Research and Innovative Care Compliance (OCRICC) and the Data Safety Monitoring Committee (DSMC.
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Serve as the WSU IRB External IRB Reliance Reviewer and Single IRB Multisite Pre-Reviewer to determine completeness and compliance with all applicable regulations and institutional polices.
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Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
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Data Management and Compliance: Lead data management planning and ensure adherence to regulatory standards like IRB, HIPAA, GLP, GCP, and FERPA. Evaluation and Reporting: Collaborate with the Senior Director to evaluate the Research Technology Core's effectiveness through detailed reports and data analysis.
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Providing nursing research support for IRB and Institutional Animal Care and Utilization Committee (IACUC) approved research protocols. Experience supporting research protocols for IRB and Institutional Animal Care and Utilization Committee (IACUC.
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With the guidance of a regulatory specialist, prepare study documents and applications for IRB submission, obtain regulatory (IRB and ancillary review) approval, submit study modifications, continuing reviews, RNIs, and ensure studies retain regulatory approvals.
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Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years Minimum Competencies (Skills, knowledge, and abilities) Ability to successfully complete the requirements of the Northwestern Memorial Hospital Research Access Program.
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The CRC B (Regulatory Coordinator) will assist with preparing and processing regulatory documents through the IRB and other research review boards and have the ability to handle a variety of clinical trial related regulatory responsibilities in accordance with University of Pennsylvania, GCP, ICF, and FDA guidelines.
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With us, youll be part of the next frontier in mental health care with an integrative treatment model and outcomes research approved by a third-party validated Institutional Review Board (IRB.
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Review human/animal research submissions, and/or conflict of interest documentation for completeness and initial regulatory review categorization and compliance prior to regulatory committee (Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Conflict of Interest (COI) review.
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The BioSafety Officer also supports various safety programs across the campus, including initiatives led by IACUC, DURC, and IRB, contributing to a comprehensive culture of safety and compliance within the university community.
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Experience with research governance, regulations, University policies, and Institutional Review Board (IRB) requirements & processes. Excellent writing skills, able to aid development and writing of literature reviews, IRB protocols, manuscripts and grants; demonstrated authorship of scientific, peer-reviewed publications is a plus.
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The postdoc will also contribute to grants management as needed throughout the project lifecycle in areas such as participant recruitment; participant orientations; drafting such documents as IRB amendments, reports, manuscripts, and/or presentations; and additional responsibilities as needed.
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Participates as an active member of the facility Institutional Review Board (IRB and serves as the facility’s expert for pharmaceutical product development, formulation, and preparation. The Broadway Center for the Performing Arts, Chihuly Bridge of Glass, Emerald Downs Racetrack, Emerald Queen Casino, Fort Nisqually Living History Museum, Lakewold Gardens, and the Mount Rainier Scenic Railroad represent a small sampling of the region's varied entertainment options.
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Creation and management of documents for Institutional Review Board ( IRB ), Institutional Animal Care and Use Committee ( IACUC ), and other study related activities. Clinical partners include Robert Wood Johnson University Hospital in New Brunswick, Newark’s University Hospital in Newark, and other affiliates.
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