职责描述:1.TheClinicalResearchAssociate(CRA)willmonitortheprogressofclinicalstudiesatinvestigativesitesorremotely,andensureclinicaltrialsareconducted,recorded,andreportedinaccordancewiththeprotocol,standardoperatingprocedures(SOPs),ICH‐GCP,andallapplicable,Regulatoryrequirements.2.ImplementsandmonitorslocalclinicaltrialstoensuresponsorandinvestigatorobligationsarebeingmetandarecompliantwithapplicablelocalregulatoryrequirementsandICH‐GCPguidelines3.Assessesthequalificationofpotentialinvestigativesites,initiatesclinicaltrialsatinvestigativesites,instructssitepersonnelontheproperconductofclinicaltrials,andcloseclinicaltrialsatinvestigativesites4.Reviewsandverifiesaccuracyofclinicaltrialdatacollected,eitheronsiteorremotely5.Providesregularsitestatusinformationtoteammembers,trialmanagement,andupdatestrialmanagementtools6.CompletesmonitoringactivitydocumentsasrequiredbyCompanyorSponsorSOPsorothercontractualobligations7.Workscloselywithotherclinicalteammemberstofacilitatetimelyresolutionoftrialand/orclinicalissues8.EscalatessiteandtrialrelatedissuesperCompanySOPs,untilidentifiedissuesareresolvedorclosed9.Performsessentialdocumentsitefilereconciliation10.Performssourcedocumentverificationandqueryresolution11.AssessesIPaccountability,dispensation,andcomplianceattheinvestigativesites12.VerifiesSeriousAdverseEvent(SAE)reportingaccordingtotrialspecificationsandrelevantlocalandICHGCPguidelines13.Communicateswithinvestigativesites14.Updatesapplicabletrackingsystems15.Ensuresallrequiredtrainingiscompletedanddocumented16.BeassignedlogisticalsupporttasksbyCTMforInvestigatorMeetings任职要求:1.2to4yearsoflocaltrialexperience;exposuretoMNCandglobalorLocalPhaseI-IVtrialsClinicalresearchexperience2.KnowledgeofICHandlocalregulatoryauthorityregulationsregardingdrug3.Anadvanceddegree(e.g.,M.S.,M.B.A.,Phar.D.,etc.)语言要求:不限
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