临床研究助理 Clinical Trial Assistant(实习生)-北京社

3K-4.5K/月

市辖区本科及以上

发布时间：2023-09-06

职位描述

职位描述：

GENERALDESCRIPTIONANDRESPONSIBILITIES:


Toperformnonpatientrelateddutiesandprovidetechnical/logisticalsupporttoClinicalResearchDepartmenttoensuretimelyandefficientinitiation,managementandclosureofclinicaltrials.Ascountryclinicalsuppliesadministratorandunderofficeheadsupervisiontocheckdrugroomtemperatureweeklyandhandlesupplies’shipmentwithcompleteddocumentationSupportthetasksbelowforassignedprojectthroughoutthestudy:
-SupportforTrialMasterFile(TMF)maintenanceinaccordancewithICH-GCPandSOPs(SMART-KMSscanning,indexingandQCwithinprescribedtimelines)
-UpdatesthetrialandsiteinformationasnecessaryinClinicalTrialManagementSystem(CTMS)–TrialWork®inatimelymanner
-Attendsappropriatetrainingprogramsandprojectteleconferencesasapplicable.
-Supportethicscommittee&regulatorysubmissions
-SupportstudyteamtouploadessentialdocumentintoSMART-KMS
OtherresponsibilitiesoftheCTA:
-ComplieswithEPSINTLPolicies,SOPs&IGsandlocalregulationsduringvariousprojectsrelatedtransactions
-Providesback-upcoverageforotherCTAasnecessary.
-SupportsProjectLeaderforproductionandtrackingoftrialmetricsmeasurements.
-SupportsProjectLeaderforcoordinatingwithsitesforfinalizingbudgetworksheetsandcontractualagreements.
-Providessupportasneededfordrugmanagementandfinancemanagement.
-Maintainsandensurestheavailabilityofinventoryforallnondrugsupplies.
-Provideslogisticandadministrativesupporttoprojectteams.
-ResponsiblefordistributionofSUSAR/safetyletterstothesites,EthicsCommitteeandregulatoryauthority,ifapplicable
-SupportsCRAtotrackstudybudgetincountryandsitelevelasapplicable.
-ProvidelogisticsupportforlocalPImeetingandCRrelatedmeeting/training.

Thisjobdescriptiondoesnotlistalldutiesofthejob.Employeesmaybeaskedbysupervisorsormanagementtoperformotherduties.

MINIMUMREQUIREMENTS:


oDiplomaorDegreeinLife-Sciencefromarecognizedinstitutions,and/orequivalentcombinationoftrainingandexperience
oGoodcoordinationskillsandabilitytoestablishandmaintaineffectiveworkingrelationshipswithalllevelswithinthecompanyandthirdparties.
EffectivetimemanagementandgoodabilitytomanagecompetingprioritiesGoodcommunicationskillsandmustbefluentinbothwrittenandspokenEnglishGoodteamplayerwithexcellentinterpersonalandorganizationalskillsHighintegrityinpersonalityandprofessionalismPositiveattitude,highdegreeofinitiative,committedandabletoworkindependentlySelf-initiativetoperformduties,withgoodanalyticalandproblem-solvingcapabilitiesAbilitytohandlemultipletasksandexpectedtofollowthroughwithcompletionofassignedtaskswithminimalsupervisionMeticulousandabletoworkinafast-pacedenvironmentAbletoworkunderpressureandunderchallengingtimelineswhenrequiredExcellentcomputerskillsandproficientinMicrosoftWord,ExcelandPowerPointAbletotravelwhenrequired

其他要求

招聘人数：1人
职能类别：临床协调员CRC

公司介绍

*ABOUTUS

EPSINTERNATIONALCO.,LTD(EPSINTERNATIONAL),aclinicalserviceproviderestablishedbyareputableleadingfullserviceJapanesecontractresearchorganization–EPSCo.Ltd(EPS),commencesitsoperationsin1999toprovideanintegrated,seamlessandoptimaldrugdevelopmentplatformthroughsynergizingEPS’slong-establishedclinicalresourcesandoperationsinAsiaregiontobestsupportincreasingoutsourcingneedsintheresearch,developmentandcommercializationofpharmaceuticalproductsandmedicaldevicesinitiatedbyglobalandJapanesecompaniesworldwide.

WehavestrongpresenceinAsiaandarefastexpandingourfootprintsinthePacific,EuropeandUS.

Websitewww.epsgr.com


*COMPANYVALUES

InlinewithEPS’scorporatevisions,EPSINTERNATIONALaimstobean“EverProgressingSystem”bycontinuouslydeliveringqualityclinicalservices,providingefficientandeffectiveturn-keysolutionsforourClients’productsdevelopmentneedsinAsiaregion.


*COMPANYSUCCESS

EPSINTERNATIONALleveragesandappliesEPS’svalueswithmanyyearsofcombinedexperiencesasanaddedvaluetoourClients’programsrangingfromresearch,developmenttocommercializationinkeyAsiancountries.Leadbyagreatteamofprofessionalswithin-depthexperiencesandrelationshipssupportedbyregionalclinicalnetworks,keyopinionleadersandgoodperformancesites,EPSINTERNATIONAListhepreferredoutsourcingpartnerinAsia.


OneofthelargeCROinJapanandlistedonTokyoNikkiStockExchange.WeareprofitableandhavestrongandstablefinancialsupportfromEPSGroup.


AfullserviceproviderfromBioanalytics(PhaseI)toPhaseIVtoCentrallab,patientrecruitmentservices,resourcesolutiontomeetclientsone-stopshopneeds


Stronglanguagecapabilitieswithintheteam-Japanese,Chinese&English.KnownasthebestJapanesestudyCROserviceprovider.


OurDataManagementGrouphasastrongbrandandreputationintheindustry


ComparativelylargeclinicaloperationteamwithwidetherapeuticareaexperiencethatspansoverAsia.