職位描述
Thisroleisresponsibleforcomprehensivetrialandsiteadministration.UndertheoversightoftheSeniorCOMorCOMs,thepersonprepares, collates, distributes and archives clinical documents.
TheCTCsupportsclinicalsupply&non-clinicalsupplymanagementandensurestimelymaintenanceoftrackingandreportingtools,asapplicable.
TheroleiscriticaltomeetplannedSiteReadydates,includingassistingwiththepreparationofsubmissionpackagestoIRB/ERCandHealthAuthorities.TherolewillcollaborateatlocallevelcloselywithCOM,CRMandCRA.Andthepersoncollaborateswithfinance/budgetingrepresentativestomanageCTRAsandpayments.
Responsibilities include, but are not limited to:
? Document management:
oPreparedocumentsandcorrespondence
oCollate,distribute/ship,andarchiveclinicaldocuments,e.g.eTMF
oAssistwitheTMFreconciliation
oExecuteeTMFQualityControlPlan
oDocumentproperdestructionofclinicalsupplies.
oObtaintranslationsofdocuments
? Regulatory & Site Start-Up responsibilities: Collaborate withother country roles to:
oInatimelymanner,providetoandcollectfrominvestigatorsforms/listsforsiteevaluation/validation,sitestart-upandsubmissions
oObtain,trackandupdatestudyinsurancecertificates
? Budgeting, Agreement and Payments:
oCollaboratewithfinance/budgetingrepresentativesfor:
oDevelop,control,updateandclose-outcountryandsitebudgets(includingSplitsitebudget)
oDevelop,negotiate,approveandmaintaincontracts(e.g.CTRAs)
oTrackandreportcontractnegotiations
oUpdateandmaintaincontracttemplates(incooperationwithLegalDepartment)
oCalculateandexecutepayments(toinvestigators,vendors,grants)
oEnsureadherencetofinancialandcomplianceprocedures
oMonitorandtrackadherenceanddisclosures,
oMaintaintrackingtools
oAndmaintenanceoffinancialsystems.
CORE Competency Expectations:
?FluentinLocalLanguagesandbusiness proficient in English(verbalandwritten)andexcellentcommunicationskills
?GoodunderstandingofGlobal,Country/RegionalClinicalResearchGuidelinesandabilitytoworkwithintheseguidelines.
?HandsonknowledgeofGoodDocumentationPractices
?GoodITskills(UseofMSoffice,useofsomeclinicalITapplicationsoncomputer)andabilitytoadapttonewITapplications.StrongMSExcelskillsrequired.
?ICH-GCPKnowledgeappropriatetorole
?ExcellentnegotiationskillsforCTCsinfinancearea
Behavioural Competency Expectations:
?Effectivetimemanagement,organizationalandinterpersonalskills,conflictmanagement
?Effectivecommunicationwithexternalcustomers(e.g.sitesandinvestigators)
?Highsenseofaccountability/urgency.Abilitytosetprioritiesandhandlemultipletaskssimultaneouslyinachangingenvironment
?Workseffectivelyinamatrixmulticulturalenvironment.Abilitytoestablishandmaintainculturallysensitiveworkingrelationships.
?DemonstratescommitmenttoCustomerfocus,bothinternallyandexternally.
?Abletoworkindependently
?Proactiveattitudetosolvingproblems/proposingsolutions
Experience Requirements:
?Minimum1yearsinClinicalResearchorrelevanthealthcareexperience
Educational Requirements:
?Bachelor'sDegree(orcomparable)inBusinessFinance/Administration/LifeScienceorequivalentHealthCarerelatedexperience
