原创力文档clinical research associate orientation and continuing education processes临床研究助理入职培训继续教育流程.pptx
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ClinicalResearchAssociateOrientationandContinuingEducationProcesses
（SOPCO-27）QATrainingDepartment
OverviewOrientationofClinicalResearchAssociateswithoutClinicalResearchAssociateExperienceOrientationforExperiencedClinicalResearchAssociatesIn-services/OngoingTraining
OrientationofCRAswithoutCRAExperienceTheCOdepartmentwillassignaCRAwithappropriateexperiencetoeachCRAnewtoIPA(Trainee)toactasamentor.TheQAandTrainingDepartment,assignedmentor,andSupervisorforTraineeswillguidehim/herthroughtheCRAorientation/trainingprocess.TheroleofthementorisalsotoensurethattheCRAisfollowingtheagreedupontrainingmanualandactasaresourceduringtraining.TheTraineewillreceiveaCRAOrientationBinder.TheQAandTrainingDepartmentwillreviewthecontentsoftheCRAOrientationBinderwiththeTrainee.
OrientationofCRAswithoutCRAExperienceTheQAandTrainingDepartmentwillreviewClinicalOperations(CO)(andother)StandardOperatingProcedures(SOPs)withtheTrainee.TheHumanResourcesandAdministrationManager/AssociatewillreviewEmployeeHandbookwithTrainees.
OrientationofCRAswithoutCRAExperienceTraineeswillundergoaseriesofmockvisitsincludingqualification,initiation,routine,andclose-outmonitoringvisits,asappropriate.Duringthemockvisits,CRAswithqualifiedexperiencewillactasthesitePrincipalInvestigator(PI)andClinicalResearchCoordinator(CRC).TheTraineewillperformthevisitsperIPASOPs.ThemockPIandCRCwillevaluatetheTrainee,discusstheevaluationwiththeCRA,andforwardevaluationformstotheQAandTrainingDepartmentwithin10businessdays.TheQAandTrainingDepartmentwillalsoprovidefeedbacktotheTraineeanddirectSupervisorforTrainees.TheevaluationswillbemaintainedintheCRAspersonnelfile.
OrientationofCRAswithoutCRAExperienceClinicalResearchAssociates,withappropriateexperienceandidentifie
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