Experience

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  Novartis vaccines and diagnostics

  Jan 2011 - now

  Clinical research associate

  Responsibilities:Site and Investigator selection Primary contact between the Investigator and SponsorEnsure that the site has adequate resources prior and during the conduct of trialReview the translation of Informed Consent forms, Diary Cards and Memory Aids Assist in the preparation of Investigator’s MeetingsConduct training of Investigator and Site Staff on Protocol and amendments, safety reporting, proper documentation and other relevant study specific trainings Preparation of study document package for submission to Ethics committees and competent authoritiesConduct initiation visit, interim monitoring visits and close-out visit to ensure compliance of Investigator and Site Staff to the approved protocol and ICH GCPVerify that the subject records and other source documents are accurate and completeEnsure data are captured in Case report forms according to the protocol and timelineEnsure that Serious Adverse events are reported to Sponsor and Ethics Committee according to the timelineEnsure that adverse events are managed by the Investigator and/or Investigator delegateReport and escalation of protocol deviations to Investigator and SponsorProvide support to Investigators and site staff in the resolution of issuesAssist Investigator in preparation for auditsWrites and submits Monitoring Visit reports according to the Monitoring PlanMaintain and review the Sponsor Trial Master FileReview and update of the Investigator Trial Master FileRequest of delivery of Investigational Product to sitesReview records of Investigational Product shipment, maintenance, administration, accountability, return and/or destructionReview of Data Listings, generate queries and follow up until resolutionCoordinate Site budget request and payment with Finance Review of Site Liquidations Show less