Contract CRA for top 5 Pharma社

8K-10K/月

市辖区本科及以上1年及以上

发布时间：2023-09-06

职位描述

职位描述：

JobDescription
ProvidessupporttoProjectTeamandClinicalOperationsTeam.
MaintainsworkingknowledgeofprotocolsandMonitoringPlansforassignedprojects.
Demonstratesstrongwrittenandverbalcommunicationskills.
Servesasprimarycontactforassignedresearchsites.
Verifiesthattheinvestigator,staff,andsitefacilitiesremainadequatethroughoutthetrialperiod.
Responsibleforschedulingandconductofpre-studyvisits,initiationvisits,interimmonitoringvisitsandclose-outvisitsaccordingtotheMonitoringPlan.
Ensuresassignedsitesareconductingstudiesaccordingtoprotocolrequirementsandapplicableregulationsandguidelines.
Reconcilessiteregulatorybinderassuringcollectionandcompletenessofregulatorydocuments.
Collectsandensurescompletenessofallessentialregulatorydocumentationfromsitesfromstudystart-upthroughclose-out.
Verifiesthatwritteninformedconsentwasobtainedbeforeeachsubject’sparticipationinthetrial.
Verifiesthattheinvestigatorisenrollingonlyeligiblesubjects.
PerformsverificationofsourcedocumentsagainstCaseReportForm/ElectronicDataCaptureentriestoassureaccurateandcompletedata.Ensuresthatanycorrectionsareappropriatelydocumentedbyauthorizedsitestaff.
Issuesandensurestimelyresolutionofalldataqueries.
PerformsInvestigationalProductaccountability,includingproductstorage,inventory,return/destruction,anddispensing/receiptrecords.
EnsuresalltypesofadverseeventsarereportedandtrackedperregulatoryrequirementsandtheMonitoringPlan.
Ensuresthatsiteshavesufficientprojectspecificsupplies.
Managesandmotivatessitestomeetstudygoals.
Communicatesdeviationsfromtheprotocol,SOPs,and/orGCP,totheinvestigator,andprojectmanagementteamandtakesappropriateactiontopreventrecurrence.
Deliversqualitywrittentripreports,confirmationandfollow-upletterswithintimelinesofSOPsandMonitoringPlans.
Attendsandparticipatesinteamteleconferencesandtraining.
Attendsinvestigatormeetings.
Participatesinsiteaudits,asrequested.
Makesrecommendationsforimprovementinprocesses.
Mayconductsiteandstudyfeasibilityassessments.
Maybeinvolvedinthedevelopmentofmonitoringguidelineandtools.
Providesinputintostudydocumentationandmonitoringworksheets.
UpholdtheconfidentialityagreementswithallclientsandcolleaguesoutsideClinipaceWorldwide(CPWW).
WorkaccordingtotheCPWWQualityManagementSystemandactivelyparticipateingivingfeedbackandsuggestingimprovementstocurrentprocesses.
Workaccordingtotheproject-specifictimelinesandbudgetagreement,whichhasbeenagreeduponwiththesponsor.AccuratelydocumentthetimespentperprojectintheCPWWtimeallocationsystem.
Demonstratesflexibilityandadaptability.
Proactivelyidentifies,manages,escalates(asneeded)andresolvessiteissueseffectivelyandindependently.
OtherdutiesasassignedbyLeadClinicalResearchAssociate/ClinicalTrialManager/ProjectManagerandperproject-specificrequirements.
MayparticipateindeliveringClinicalMonitoringportionofabiddefensepresentation.

Requirement:
Atleast2yearsCRAworkingexperienceinmultinationalpharmaceuticalcompanyorCRO
HaveglobalPhaseIIIclinicaltrialsexperience.
Familiarwithclinicaltrailsystem.
GoodEnglishskills,willingtolearn,hardworking.
Candidateshouldbemajorinclinicalmedicineorpharmacy.

其他要求

招聘人数：3人
职能类别：临床协调员CRC

公司介绍

InJan2014,ChoicePharma(丘以思(上海)医药信息咨询有限公司)mergedwithClinipaceWorldwide.ClinipaceWorldwideisaglobalfull-servicedigitalcontractresearchorganization(dCRO)thathaspioneeredaninnovativeservicemodeltotransform
drugandmedicaldevicedevelopmentbydeliveringtechnology-amplifiedservicestoimprovestudyperformance,collaboration,andtransparencyacrossallstakeholders.Frommanagingyourentiredevelopmentprogramtoconductinganindividualclinicaltrial,ourexpertsbringextensivetherapeuticandlocalexperienceinbuildingawell-definedclinicalplantomaximizeyoursuccess.PoweredbyTEMPO?–ourproprietaryeClinicaltechnology–ourteamsensureyoursuccessandbringunsurpassedefficiency,quality,andvisibilitytoyourdevelopmentprograms.
NowClinipaceWorldwideranksthe10thCRO,anddevelopesrapidly.