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1、XXXXXDOB:MMM.YYYYGender:Ma1.eNativep1.ace:XXXXXcity,XXXXXProvinceMajor:C1.inica1.Medicine&Mo1.ecu1.arOnco1.ogyPhone:139XXXXXXXXEmai1.:XXXXXXXXObjectiveSeniorCRAorCRA11(1.ocatedinShanghai)SunnaryCertifiedCRAofACRP,March201May31,2013;MorethantwoyearsexperiencesasaC1.inica1.ResearchAssociate;In-depthkn
2、ow1.edgeofHe1.sinkiDec1.aration,ICH-GCPGuide1.inesandSOPs;Se1.f-studyofIDCFRon1.ine:Therapeuticareasinc1.udecancer,endocrineandcardiovascu1.ardiseases;Goodunderstandingofmedica1.termino1.ogy;Fami1.iaritywithEDC,IVRS/1WRSandcentra1.1.aboratoryprocedures;Exce1.1.entinterpersona1.ski1.1.sandfastpriorit
3、izationoftasks;Strongsenseofse1.f-discip1.ine;Goodspiritofteamwork:F1.uentinAmericanEng1.ishandMandarin;Enjoytrave1.1.ing.Education20052008,Master;Biomedica1.researchesonMo1.ecu1.arOnco1.ogy;FudanUniversity,Shanghai,China20002005,Bache1.or;C1.inica1.Medicine;UniversityofSouthChinaWorkExperienceI. Ma
4、r2011-June2011,ResearchAssistantatBuckInstituteforResearchonAgingJobDescription:Assistinthedesign,preparation,imp1.ementationofexperiments,andana1.ysisoftheresu1.tstoexp1.orethecompoundsthatcanextend1.ifespanofanima1.mode1.sandtheircorrespondingmo1.ecu1.armechanisms,aswe1.1.astofindnewstrategiesfort
5、hetreatmentofneurondegenerativediseasessuchasA1.zheimer*sdiseaseandParkinson,sdisease;Acquiredawe1.1understandingofAmericancu1.tureandimprovedcommunicationski1.1.sinEng1.ishthroughthisjob.II. Sep2010-Mar2011,MemberofAssociationofC1.inica1.ResearchProfessiona1.(ACRP)(1) Systematica1.1.yIearningofICH-
6、E6,ICH-E8,ICH-E2AandACRPrecommendeddocuments,suchasGuidetoC1.inica1.Tria1.s-,(2) PassedtheexaminationofCertifiedC1.inica1.ResearchAssociate(CCR);(3) Studythec1.inica1.tria1.regu1.ationsofFoodandDrugAdministration(FD):(4) Invo1.vedinthediscussionofmonitoringandmanagementofc1.inica1.tria1.sintheeForum
7、ofACRP,bui1.ttheknow1.edgeonthestatusquoofc1.inica1.tria1.industryinUS.III. Apr2009-Aug2010,ContractCRAinOmnicareC1.inica1.Research(China),basedinBoehringer-Inge1.heim(Shanghai)MainResponsibi1.i1.ies:(1) Se1.ectappropriatesitestoconductc1.inica1.tria1.s;(2) Negotiatewithprincipa1.investigatorstoconc
8、1.udec1.inica1.tria1.contracts;(3) PrepareIRB/IECsubmissiondocuments;(4) Conductinitiationmeetingtostartatria1.withinrequiredtime1.ine;(5) Performperiodicmonitoringvisitstodiscussrecruitmentwithinvestigators,toverifytria1.dataagainstsourcedocuments,tocoordinatewiththereso1.utionofqueries,tofaci1.ita
9、tethereportofSE,tocheckrecordsregardinginvestigationa1.products,toassistwiththearrangementofessentia1.documents,andu1.timate1.y,toprotectthesafety,rightsandwe1.1.-beingofsubjectsandtokeephighqua1.ityaswe1.1asgoodprogressofc1.inica1.tria1.s;(6) Makec1.oseoutvisitsaccordingtoSOP,ICH-GCPandapp1.icab1.e
10、regu1.ations;(7) 1.iaisonbetweensiteandsponsorforother1.ogisticaffairs;(8) Writere1.evantreportsaccordingtoSOP.Achievements:(9) Responsib1.eformonitoring2tria1.s,inc1.uding7sitesand71ongoingsubjectssimu1.taneous1.y;thiswasthehighestwork1.oadamonga1.1.CR.sinBoehringer-Inge1.heim.Moreover,therecruitme
11、ntwasfasterthanmostco1.1.eagues,sites,RDCverificationratewaskeptnear80%,anda1.1.tria1.re1.ateddocumentswerefi1.edwe1.1insites;(10) 4subjectswererecruitedwithinonemonthafterinitiationvisitofag1.oba1.phaseIIItria1.Thisrecruitmentratewas7timeshigherthantheaveragerecruitmentspeedthatwas2subjectsevery4mo
12、nths;(11) 43e1.igib1.esubjectswereenro1.1.edwithintwomonthsforag1.oba1.phaseIVtria1.Thistime1.inewasmorethantwomonthsaheadofg1.oba1.p1.an:(12) 25subjectswererecruitedforaphaseIc1.inica1.tria1.withinonemonth,a1.1EDCquerieswerereso1.vedontime,a1.1essentia1.documentswerefi1.edwe1.1.andsamp1.esweresentt
13、oUKwithinschedu1.e.IV. Ju1.2008-Mar2009,CRAinShanghaiZhangjiangBiotechno1.ogyCo.1.td.Mainjobsandaccomp1.ishments:(1) Invo1.vedinthemonitoringofonephase1andonephaseHitria1.ofanti-tumordrugs;(2) PresidedoveroneinitiatingmeetingofaphaseI1.1.tria1.High1.ypraisedbyinvestigatorsforoutstandingpresentations
14、ki1.1.sandc1.oseattentiontodetai1.s;(3) Periodicmonitoringvisitsfor6sites.Enhancetherecruitmentfrom12subjectspermonthto16;(4) Wroteresearchsummaryforinvestigationa1.products.Acquiredabroadknow1.edgeonanti-tmorproducts;(5) .Assistintheorganizationofaninvestigators,meeting;(6) Editeds1.idesforoneinves
15、tigators,meeting.TraineeExperience(1) pr2010,CREssentia1.Ski1.1.sTrainingCoursesprovidedbySeniorTrainingDirectorMr.1.ainSear1.eofOmnicareC1.inica1.Research.Maintopicsinc1.udetheresponsibi1.itiesandproceduresaboutfourtypesofmonitoringvisits:pre-tria1.visit,initiationvisit,periodicmonitoringvisitandc1.oseoutvisit;(2) May/2009,RDCOnsiteC1.assroomTrainingforCRAsinBoehringer-Inge1.heim:(3) May2008-0ct2008,InternationaCRATrainingCoursesofferedbyJackXu,whoistheformerMedica1.DirectorofQuinti1.esMcdicaiDeve1.opment(Shanghai).