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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.
$23 - $29.87 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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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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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 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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Extract (using SQL Server Management Studio (SSMS) and T-SQL) and analyze (using statistical software such as SPSS and Stata) data from CCS databases, and the State Board for Community and Technical Colleges (SBCTC) data warehouses for use in research projects and report generation.
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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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B) the Health Sciences Institutional Review Board (HSIRB) and the Institutional Review Board for the Protection of Human Subjects #1 (IRB #1) Works closely with the Grants Manager and Director Human Subjects Administration to ensure efficient and effective delivery of Office of Sponsored Programs services as part of the Office of the Senior Vice President for Research Affairs.
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Minimum of two (2) to four (4) years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience. A minimum of two (2) years as a Clinical Research Coordinator within the past five years OR Current certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA.
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Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
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JOB SUMMARYAt Houston Methodist, the Manager Research Protection position is responsible for providing specialized administrative support, regulatory compliance review and management of specific regulatory committees in the Houston Methodist Hospital Research Institute (HMRI) which include the Institutional Care & Use Committee (IACUC), Institutional Biosafety Committee (IBC) and Hazardous Substance Committee (HSC.
$87,000 - $115,000 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Oversees research activities by coordinating Institutional Review Board (IRB) approved research studies with the Pathology Research Coordinator ensuring research requests are completed and billed properly.
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An experienced clinical research coordinator-C will be involved in multiple local and multi-institutional clinical research studies in the Department of Neurology related to traumatic brain injury.
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10% Assist/supervise research assistant in preparing subjects applications, consent and HIPAA forms and progress reports for the Institutional Review board. Prepare subjects applications, consent and HIPAA forms and progress reports for the Institutional Review board.
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Collaborates with the Project Director- Federal Grants, Director of Outcomes and Evaluation, and Clinical Director(s) to ensure compliance to project-specific outcomes and federal guidelines (, reporting, Institutional Review Board.
$91,353.6 - $107,348.8 a yearFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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Description/Job Summary The Research Analyst II reports to the Director of Institutional Research and provides general institutional support through data extraction, collection, analysis and reporting, as well as survey design and administration.
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clinical research institutional review board jobs Company: Children's Hospital Colorado
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