职位描述: RESPONSIBILITIES:1.Participatesinsitefeasibilityand/orpre-trialsiteassessmentvisits,providingrecommendationfromlocalareaaboutsite/investigatorselectionincollaborationwiththetrialteam2.Actsasprimarylocalcompanycontactforassignedsitesforspecifictrials.3.Attends/participatesininvestigatormeetingsasneeded.4.Responsibleforexecutingandreturnsareaccuratelyinventoriedanddocumented.activitieswithinsiteinitiationandstart-up,sitemonitoring,sitemanagementandsite/studyclose-outaccordingtointernalSOPs/WIs/IFUsandpolicies.5.Ensuressitestaffaretrainedandthecorrespondingtrainingrecordsarecompleteandaccurateatanytimepointduringalltrialphases.6.Contributestositelevelrecruitmentstrategyandcontingencyplanningandimplementationinpartnershipwithotherfunctionalareastoachieveclinicalresearchtarget.7.Ensuressitestudysupplies(suchasNon-IP,labkits,etc.)areadequatefortrialconduct.8.Ensuresthatclinicaldrugsuppliesareappropriatelyused,handledandstored9.Arrangesfortheappropriatedestructionofclinicalsupplies10.Ensuressitestaffcompletethedataentryandresolvequerieswithinexpectedtimelines.11.Ensuresaccuracy,validityandcompletenessofdatacollectedattrialsitesEnsuresthatallAEs/SAEs/PQCsarereportedwithintherequiredreportingtimelinesanddocumentedasappropriate.ForAEs/SAEs,ensuresthattheyareconsistentwithalldatacollectedandwiththeinformationinthesourcedocuments.EDUCATIONANDEXPERIENCEREQUIREMENTS:AminimumofaBA/BSdegreeisrequired.Adegreeinahealthorsciencerelatedfieldispreferred.Aminimumof2yearsofclinicaltrialmonitoringexperienceispreferred.Specifictherapeuticareaexperiencemayberequireddependingontheposition.StrongworkingknowledgeofICH-GCP,companystandardoperatingprocedures,locallawsandregulations,assignedprotocolsandassociatedprotocolspecificproceduresincludingmonitoringguidelines.StrongITskillsinappropriatesoftwareandcompanysystems.Willingnesstotravelwithoccasionalovernightstayawayfromhome.ProficientinspeakingandwritingthecountrylanguageandEnglish.Goodwrittenandoralcommunicationskills.
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