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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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Reviews study with principal investigator and/or clinical research coordinator to a budget outlining standard of care and research costs. 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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The Clinical Research Coordinator assists the investigator team to develop study protocols and manuals of procedures. The Clinical Research Coordinator screens, enrolls and follows study participants, conducts data collection and entry, performs noninvasive cardiovascular tests according to study protocols, and conducts small group coaching sessions.
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The compliance audit process includes but is not limited to:oCommunicating with Principal Investigator (PI) and designated study staff, oPerforming remote and onsite review of study regulatory and subject files, oProviding education and study management support to the PI and research team, oProviding a written report and assessment of noncompliance,oCompleting follow up to ensure corrective actions are implemented and the needs of the study staff are fully addressed.
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As a Clinical Research Associate I, you will work directly with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate and/or implement the study.
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Working independently under the Principal Investigator, the CRC will be responsible for carrying out clinical research studies, including but not limited to participant recruitment and enrollment, scheduling study visits, carrying out study procedures, data collection and transfer to data repositories, and maintaining study records.
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Directly involved with study start-up, implementation, conduct, and close-outs. Completes applications and obtains appropriate approvals from various groups for all necessary study start-up functions.
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Function as a Clinical Data Manager (CDM) to coordinate the day-to-day support of CDM results from study start-up through to database lock to receipt of final study outputs for clinical studies outsourced to contract research organizations.
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The Clinical Research Coordinator will manage study activities, including study recruitment, scheduling, patient consent, data collection/entry, reporting, and participant survey follow-up.
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Provides study start-up documents (paper or electronic) to Clinical Research Regulatory Coordinator. The Clinical Research Coordinator is responsible for the efficiency and accuracy of clinical studies through all stages as the study progresses and show vigilance in participant safety, protocol compliance, and data quality.
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Lead the study start-up process, including, but not limited to, the Trial Kick-off meeting, the set-up of the trial master file (TMF), the set-up of the electronic data capturing (EDC) system, site selection, and the finalization of site Clinical Trial Agreements and budgets.
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Under the direction of the Principal Investigator (PI) and Cardiology Research Nurse Manager, collaborate with all members of the clinical research team to ensure all federal, state, university, and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept.
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JOB SUMMARY: The Clinical Research Nursing Coordinator works collaboratively with the Principal Investigator and other research staff to support study implementation.
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Conduct and participate in research including, but not limited to, performing as the primary investigator or co-investigator for research programs which will impact on the delivery of quality care or examine the pharmacoeconomic impact of providing care to the patients in the Duke Health System.
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Then you might be a great fit for a Senior Clinical Research Coordinator role with DaVita Clinical Research (DCR)We are looking for a highly motivated, positive and innovative senior level Clinical Research Study Coordinator (Research Coordinator) to lead in the coordination, management and conduct of nephrology clinical research trials in dialysis centers and physicians practices.
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clinical research investigator study start up jobs Company: M3 Global Research
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