EducationandWorkExperience:1.Bachelor’sDegreeinalliedhealthfields:Medical,Nursing,Pharmacy,Psychology,VeterinaryorHealthScience2.Minimumof1yearsexperienceasaClinicalResearchAssociateKnowledge,Skills,andAbilities:1.Excellentverbalandwrittencommunicationskills2.GoodverbalandwrittenEnglishlanguageskills3.Strongcomputerliteracye.g.MSword,Excel,PowerPoint,internet4.Excellentorganizational,recordretention,andtimemanagementskills5.KnowledgeofICH-GCP,applicablelaw(localandcountry)andregulatoryrequirementsDutiesandResponsibilities(includingbutnotlimitedto):1.Adherewithcorporateinternalpolicesandrequirements,includingsubmissionoftimesheetsandexpensereportsinatimelymanner.2.Conductstudyfeasibilityandsiteselectionactivities3.Developandimplementinnovativeapproachesforandparticipatesinsiterecruitment,selectionandinitiationactivities.4.Assistwithinvestigatormeetingactivitiesincludingorganization,preparationandattendance5.Conductsitemanagementactivitiesincludingbutnotlimitedtositeselectionvisits,siteinitiationvisits,sitetraining,siteroutinemonitoringvisits,andsitecloseoutvisits.6.Ensuretheintegrityofclinicaldataandadherencetoapplicableregulatory,protocol,andcompanyguidelines.7.Establishandmaintaingoodrapportwithstudysites.8.WritestudyvisitsreportsandfollowupletterswithinthetimelineestablishedbyapplicableSOPsandguidelines9.RepresentationofCRAsduringanauditorinspectionwhenassigned10.Coordinatetimelyshipmentofclinicalsuppliesandstudydrugtosites.11.Ensureproperstorage,dispensationandaccountabilityofclinicalsuppliesandstudydrug.12.Maintainadequatesitetrackingrecords13.Followupofdrugsafetyissuesandsafetyreportsintimelymanner,ifapplicable14.Communicatesitestudyissues,concerns,andprogresstoProjectManager,ClinicalTeamLeadandClinicalResearchManageraccordingly15.Developandimplementationofcorrectiveactionswhenappropriate16.Assistwithdataqueryform(incl.queryprocess)17.Prepare/reviewallpatientstrackingrecords18.Inputandmaintainstudyinformationconcerningsubjectstatusoffinancialreimbursementtosi
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