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研究监查岗位职责
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临床研究监查员CRA上海百利佳生医药科技有限公司上海百利佳生医药科技有限公司,百利佳生PositionDescription:
TheClinicalResearchAssociate(CRA)isresponsibleformanagingandmonitoringtheconductofclinicalprojectsaccordingtoICH-GCP,StandardOperatingProcedures(SOP)andapplicableProjectManagementPlan(PMP)andlocalregulatoryrequirements.
Responsibilities:
Contributecomments/inputinthedevelopmentofProtocol,InformedConsentForm(ICF),CaseReportForms(CRF)andotherprojectrelateddocuments.
EvaluationpotentialsiteswiththeassistancefromtheseniorCRA,PMorlinemanagerandprovidePMwithrecommendationsforselectionofqualifiedsites.
Preparethepackageforinstitutionalreviewboards(IRB)andlocalregulatoryauthoritysubmissionsandobtainIRB/regulatoryapprovalsforconductingtheclinicaltrial.
AssistPMinstart-upmeeting.
Prepareandmanagetheclinicaltrialagreementswithinvestigators/sites.
Track,manageandcontrolthesitebudgetandexpenseswithinapprovedbudgetandinlinewiththeprojectmilestonesasrequested.
Manage/coordinatetheinvestigationalproductsandclinicaltrialmaterialsforthesitesincompliancewithregulatoryrequirements.
Monitorandreporttheprojectstatusatthesitesinatimelymanner.
Keycontactpersonforthecommunicationbetweenthesitesandstudyteam.
Prepare,arrangeandconductthetrainingofsitepersonnel.
Conductsiteinitiation,monitoringandsiteclose-outvisitsincompliancewithmonitoringplan,ICH-GCP,SOPs,localregulationsandotherapplicableproject-specificplans.
PreparemonitoringreportaccordingtotheSOP.
Assisttheinvestigatorforauditing/inspectionofproject.
Coordinatewiththesitestoensurealladverseeventsandfollow-upareappropriatelyreportedandreconciledaccordingtoregulations.
Identify,analyzeandresolvetheissuesattheinvestigatorsites.
Qualifications:
A1-yearBS(BachelorofScience)degreeorequivalenceexperience.Advanceddegreeisaplus.
Atleast1yearexperienceinclinicalresearchenvironment.
GoodcommandofwrittenandspokeninEnglishorothersecondlanguage.
Goodorganizationandcommunicationskills.
Highattentiontodetailandaccuracy.
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