职责要求:• Drivestudyperformanceatthesites.Performsitemonitoringandotheronsitevisitactivitiesaccordingtomonitoringplanandincompliancewithproceduraldocuments.Providetherequiredmonitoringvisitreportswithinrequiredtimelines.Proactivelyidentifystudy-relatedissuesandescalatestoLocalStudyTeamsasappropriate.• Contributetotheselectionofpotentialsitesandinvestigators.Train,supportandadviseInvestigatorsandsitestaffinstudyrelatedmatters.• ObtainandmaintainessentialdocumentationincompliancewithICH-GCP,ProceduralDocumentsandlocalregulations.Managestudysupplies(ISF,CRF,etc),drugsuppliesanddrugaccountabilityatstudysites.• PerformsourcedataverificationaccordingtoSDVplan.Ensuredataqueryresolution.Workwithdatamanagementtoensurequalityofthestudydata.• EnsureaccurateandtimelyreportingofSeriousAdverseEvents.• SharerelevantinformationonpatientrecruitmentandstudysiteprogresswithinlocalStudyTeam.UpdateVCVandothersystemswithdatafromcentresasperrequiredtimelines.• PrepareforactivitiesassociatedwithauditsandregulatoryinspectionsinliaisonwithlocalStudyTeamLeadandQA.任职资格:• Bachelordegreeinbiologicalscienceorhealthcare-relatedfield.,orequivalent• Lessthan2-yearexperienceasaclinicalmonitor,performedalltasksforaCRApositionorjoinedCRAtraineeprogramorequivalence.• Understandingoftheclinicaldataflow.• Goodknowledgeoftheclinicalstudyanddrugdevelopmentprocesses,GCP/ICHguidelinesandrelevantlocalregulations.• GoodcomputerskillsinMicrosoftandothersoftware.• FluentinbothoralandwrittenEnglish.• Proficientwrittenandverbalcommunicationskills,collaborationandinterpersonalskills.语言要求:英语行业要求:全部行业
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