Inbar Kushnir
Clinical Research Associate i @ICON plc
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WORK HISTORY
Clinical Research Associate i @ICON plc
Providing trial monitoring services to AmgenFamiliarity with ICH-GCP and appropriate regulations.Maintain timelines. Ensure accuracy and completeness of data entered into ICON systems.Familiarity with principles of investigator recruitment.Assist with coordinating all the necessary activities required to set up and monitor a study, including the following: Identify investigators, help, when requested, in preparation of regulatory submissions. Design patient information sheets and consent forms.Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.Pre-study/placement and initiation visits.Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP/WP as appropriate.Maintain all files and documentation pertaining to studies. Motivate investigators in order to achieve recruitment targets. Complete accurate study status reports.Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.Process case record forms to the required quality standards and timelines. Deal with sponsor generated queries in a timely manner.Ensure the satisfactory close-out of investigator sites. Ensure correct archiving of files on completion of a study.Co-operate with sponsor and/or ICON QA personnel in the conduct of QA audits. Participate in feasibility studies for new proposals, as requiredEnsure storage conditions and acceptable supplies are providedEnsure IPs are supplied only to eligible patientsEnsure IP receipt, use and return are controlled and documentedEnsure disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.To participate, if requested, in the preparation of and review of study documentation e.g, draft protocols, draft CRFs, monitoring guidelines and elements of final report.Participate in data listing reviews, as applicable.
EDUCATION
University of Warwick
Bachelor of Science - BS
University of Warwick
Master of Biomedical Sciences
ABOUT INBAR KUSHNIR
Highly motivated and detail-oriented Clinical Trials Practitioner with expertise in data…
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