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This will include, but is not limited to, sponsor provided and IRB approved Protocol Training, all relevant Protocol Amendments Training, any study specific Manuals Training as applicable, sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training.
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Oversee and perform data collection in a manner that is consistent with Standard Operating Procedures, the study protocol, and the standards of GCP. Provide leadership in the CRU in the absence of the Study Coordinator.
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Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Packaging Vendors, CRO's, IRT Organizations, and Global Clinical Supply Chain Functional Operations to ensure all needs are met.
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Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents and assigned study protocol(s). Making sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s.
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A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor.
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Using a disease-specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study-specific training, data collection, and specimen collection and processing.
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The Clinical Research Nurse will execute tasks performed in compliance with study protocol, Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs). The Clinical Research Nurse will oversee the safety and consent of clinical trial participants during study conduct and the maintenance of safety equipment.
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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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Sonographer will specialize in transthoracic echocardiographic studies according to departmental and IAC protocol (which consist of M-mode, two-dimensional echocardiograms, color flow, pulsed wave and continuous wave Doppler.
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At Houston Methodist, the Clinical Research Specialist position is responsible for supporting multiple projects under supervision of Clinical Trials Manager which may include clinical research protocols, gathering patient data via methods specified in the study protocol, study reports.
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The CRA II will be responsible for the study start up process for AtriCure’s Clinical Investigational protocols, which includes and is not limited to the following: protocol review, Informed Consent Development, CRF design, EDC testing, preparation of site-specific logs/documentation and investigator study files.
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Plan observational studies and draft protocol synopsis (or protocol concept sheet) Draft and review observational study analysis specifications, including statistical analysis plans (SAPs.
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Assist regulatory staff with study regulatory reporting requirements and IRB policies for protocol deviations, safety reporting and continuing reviews. Coordinate and conduct the operation of clinical trials as per GCP and ICH guidelines including participant recruitment; informed consent; continuous monitoring of protocol for compliance and patient safety; source document review; data entry; sponsor monitoring.
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Quality Control Participates in the review of draw sheet instructions prepared by others in the research team to ensure that protocol specific details are consistent with the study documents.
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Use study protocol, CRF, Data Transfer Agreements from vendors, data sources, CDISC CT, TAUGS, and CDISC implementation guides to independently author SDTM specifications from scratch; use Pinnacle 21 to run data conformance and create define.
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