DutiesandResponsibilities(includingbutnotlimitedto):Adherewithcorporateinternalpolicesandrequirements,includingsubmissionoftimesheetsandexpensereportsinatimelymanner.ConductstudyfeasibilityandsiteselectionactivitiesDevelopandimplementinnovativeapproachesforandparticipatesinsiterecruitment,selectionandinitiationactivities.Assistwithinvestigatormeetingactivitiesincludingorganization,preparationandattendanceConductsitemanagementactivitiesincludingbutnotlimitedtositeselectionvisits,siteinitiationvisits,sitetraining,siteroutinemonitoringvisits,andsitecloseoutvisits.Ensuretheintegrityofclinicaldataandadherencetoapplicableregulatory,protocol,andcompanyguidelines.Establishandmaintaingoodrapportwithstudysites.WritestudyvisitsreportsandfollowupletterswithinthetimelineestablishedbyapplicableSOPsandguidelinesRepresentationofCRAsduringanauditorinspectionwhenassignedCoordinatetimelyshipmentofclinicalsuppliesandstudydrugtosites.Ensureproperstorage,dispensationandaccountabilityofclinicalsuppliesandstudydrug.MaintainadequatesitetrackingrecordsFollowupofdrugsafetyissuesandsafetyreportsintimelymanner,ifapplicableCommunicatesitestudyissues,concerns,andprogresstoProjectManager,ClinicalTeamLeadandClinicalResearchManageraccordinglyDevelopandimplementationofcorrectiveactionswhenappropriateAssistwithdataqueryform(incl.queryprocess)Prepare/reviewallpatientstrackingrecordsInputandmaintainstudyinformationconcerningsubjectstatusoffinancialreimbursementtosites.Conductandassistwithadministrativeactivitiesasamemberoftheprojectteam.EducationandWorkExperience:Bachelor’sDegreeinalliedhealthfields:Medical,Nursing,Pharmacy,Psychology,VeterinaryorHealthScienceMinimumof2yearsexperienceasaClinicalResearchAssociateKnowledge,Skills,andAbilities:ExcellentverbalandwrittencommunicationskillsGoodverbalandwrittenEnglishlanguageskillsStrongcomputerliteracye.g.MSword,Excel,PowerPoint,internetExcellentorganizational,recordretention,andtimemanagementskillsKnowledgeofICH-GCP,applicablelaw(localandcountry)andregulat
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