临床监查员CRAII（外派外资药厂）

岗位职责

职责要求：• Driveperformanceatthesites.Performsitemonitoringandotheronsitevisitactivitiesaccordingtomonitoringplanandincompliancewithproceduraldocuments.Providetherequiredmonitoringvisitreportswithinrequiredtimelines.Proactivelyidentifystudy-relatedissuesandescalatestoLocalStudyTeamsasappropriate.• Contributetotheselectionofpotentialinvestigators.Train,supportandadviseInvestigatorsandsitestaffinstudyrelatedmatters.• ObtainandmaintainessentialdocumentationincompliancewithICH-GCP,ProceduralDocumentsandlocalregulations.Managestudysupplies(ISF,CRF,etc),drugsuppliesanddrugaccountabilityatstudysites.• PerformsourcedataverificationaccordingtoSDVplan.Ensuredataqueryresolution.Workwithdatamanagementtoensurequalityofthestudydata.• EnsureaccurateandtimelyreportingofSeriousAdverseEvents.• SharerelevantinformationonpatientrecruitmentandstudysiteprogresswithinlocalStudyTeam.UpdateVCVandothersystemswithdatafromcentresasperrequiredtimelines• PrepareforactivitiesassociatedwithauditsandregulatoryinspectionsinliaisonwithlocalStudyDeliveryTeamLeadandQA.• 任职资格：• Bachelordegreeinbiologicalscienceorhealthcare-relatedfield,orequivalent• Minimum2-yearexperienceasCRAorotherrelatedfields.Experienceasaclinicalmonitor,performedalltasksforaCRAposition.• KnowledgeoftheMonitoringProcess,suchasunderstandingoftheStudyDrugHandlingProcessandtheDataManagementProcess,etc.• Understandingoftheclinicaldataflow• Solidknowledgeoftheclinicalstudyanddrugdevelopmentprocesses,GCP/ICHguidelinesandrelevantlocalregulations• GoodcomputerskillsinMicrosoftandothersoftware.• FluentinbothoralandwrittenEnglish.• Proficientwrittenandverbalcommunicationskills,collaborationandinterpersonalskills.语言要求：英语行业要求：全部行业