临床研究项目专员岗位职责

临床研究经理-项目经理-主管-专员MainTasks&Responsibilities

1.Contributecountryspecificaspectsinthedevelopmentofprotocol,protocolrevisions,amendmentsandCRFdesign;

2.Responsibleforthemanagementofdesignatedsitesinclinicaltrialincluding:

Siteassessment;Preparationofthemonitoringplanandexecutionincompliancewithvisitfrequencyandallassignedtasksthroughoutthestudy;PlanningandExecutionofStudyLogisticsPlan,includingeventualdelegationofactivitiestoSupportGroup;Safetyandproperconductthroughoutthetrial.

3.Sitespecificdatamanagement;

4.PreparedocumentationforIRB/ECsubmission/approval,togetherwithStudyManagementpercountryspecificrequirements;

5.PrepareandreviewclinicalstudyagreementsandbudgetswithStudymanagerandContractsgroup;

6.Ensureproceduresareinplaceforappropriateenrollmentofpatientsintotheclinicaltrial;

7.Organizeinvestigator’sstart-upmeetingandstudysiteinitiationmeetings,includingtrainingoftheexternalstudypersonnelintheuseoftheinstrumentsandreagentsandsoftwarepackagesfortheon-linedatacaptureandforthecomputerbasede.g.withWinCAEvandtrainingintheuseofelectronicaCRFswithremotedataentry;8.Responsibleforinstrumentinstallation,checkandvalidation(internalandexternal)forsystemstudy.Ifapplicable,prepareworkflowsheetforsystemstudies,togetherwithStudyManagement;

9.Responsibleforlogisticsofrequiredevaluation/clinicaltrialmaterial.Informsandmonitorssitesforcorrectstorageconditions;

10.Preparationofallstudybinders;

11.PerformInvestigatorTraining(Compliance&Technicalpart).

12.VerifytheinvestigatorfollowstheapprovedprotocolandallGCPprocedures;

13.Verifyallresearchstaffandfacilitieshaveadequatequalificationsandresourcesremainadequatethroughoutthedurationofthestudy;

14.Keycontactforcommunicationsbetweenthesponsorandtheinvestigator;thepointoffirstcontactwheninvestigators/sitepersonnelenquireaboutpatientinclusion/exclusioncriteriaforongoingtrials;

15.EnsurethatobservationsduringstudiesarecorrectlytrackedandforwardedtotheresponsibledepartmentsinXXXX;

16.Verifythatsourcedata/documentsandothertrialrecordsareaccurate,complete,andmaintained.Regardingtheresultcalculations:ensuretheusabilityofvalidatedcomputerprograms/softwareandresultcalculationincompliancetoapplicableSOPs;17.Communicatedeviationsfromtheprotocol,SOPs,GCP,andtheapplicableregulatoryrequirementstotheinvestigator;

18.Interpretsandevaluatesresultswithrespecttothestudygoalsand,ifnecessary,discusswiththesite,thestudymanager,eg.Interruptionofthestudyorinitiationofadditionalmeasurementsattheexternalsite;

19.Performtroubleshootingforunexpectedresultsaccordingtostudymanagerorprotocol’srequirements;

20.EnsurecompletionandavailabilityofStudyDocumentation,togetherwithStudyManagement;21.Adverseevents,concomitantmedications,andintercurrentillnessesarereportedinaccordancewiththeprotocol;22.ConductStudyClose-outvisitsaccordingtomonitoringplan;

23.EnsureeCRFandWinCAEvarereadyfordatabaselock;

24.ArchiveStudyRecords/Databaseaccordingtoguidelines;

25.Responsibleforpoststudysample/reagents/investigationaluseproducts/instrumentsdispositioncompletedduringtheClose-Outvisit;26.Participationinprojectteams,globalconferencecallsand/ormeetingstoreviewprogressofongoingclinicaltrialsandtoassessdevelopmentofnewprojectsregardingcustomerusability,practicabilityandSOPdevelopment,tocontinuouslyimprovequalityandefficiencyoftheevaluationteamandprocesses;

27.Contributetothecontentofthestudyreportandcontributetopublicationsforjournalsandcongresses.

PossibleAdditionaltasksforSeniorPositionHolders;

28.ResponsibleforInvestigatorSelection(accountabilitylieswithStudyManager)

29.Providementoring,includingtrainingonthejob,tothenewCRAstoensurethattheirroleandcontributionisoptimized.

BasicRequirementsoftheJob

1.Bio-medicalrelatedscientificdegree;canvaryfromabachelor,masterandnursingqualifications;

2.Knowledgeofapplicablestandardsanregulationsforclinicaltrialsandlabconduct(InternationalConferenceonHarmonization/WHOGoodClinicalPracticestandards(ICH-GCP),IVDdirectives,FDAregulations)

3.Practicalexperienceinstudymonitoringaccordingtoglobalstandards(ICH)

4.2-5yearsofClinicallaboratoryexperience;

5.DemonstratedexperienceincomputerskillstoincludeMicrosoftWord,Excel,andbasictemplates;

6.Basicstatisticalknowledge;

7.ProfessionaluseoftheEnglishlanguage;bothwrittenandoral;

8.Openandclearcommunicator;

9.Abilitytomakesounddecisionsandanalyzeandsolveproblems;

10.ConscientiousandprecisedeliveryofworkevenwhenunderpressureJD为参考。经理-专员各级别都有。

背景优先级:1IVD2CRO3器械4药MainTasks&Responsibilities

1.Contributecountryspecificaspectsinthedevelopmentofprotocol,protocolrevisions,amendmentsandCRFdesign;

2.Responsibleforthemanagementofdesignatedsitesinclinicaltrialincluding:

Siteassessment;Preparationofthemonitoringplanandexecutionincompliancewithvisitfrequencyandallassignedtasksthroughoutthestudy;PlanningandExecutionofStudyLogisticsPlan,includingeventualdelegationofactivitiestoSupportGroup;Safetyandproperconductthroughoutthetrial.

3.Sitespecificdatamanagement;

4.PreparedocumentationforIRB/ECsubmission/approval,togetherwithStudyManagementpercountryspecificrequirements;

5.PrepareandreviewclinicalstudyagreementsandbudgetswithStudymanagerandContractsgroup;

6.Ensureproceduresareinplaceforappropriateenrollmentofpatientsintotheclinicaltrial;

7.Organizeinvestigator’sstart-upmeetingandstudysiteinitiationmeetings,includingtrainingoftheexternalstudypersonnelintheuseoftheinstrumentsandreagentsandsoftwarepackagesfortheon-linedatacaptureandforthecomputerbasede.g.withWinCAEvandtrainingintheuseofelectronicaCRFswithremotedataentry;8.Responsibleforinstrumentinstallation,checkandvalidation(internalandexternal)forsystemstudy.Ifapplicable,prepareworkflowsheetforsystemstudies,togetherwithStudyManagement;

9.Responsibleforlogisticsofrequiredevaluation/clinicaltrialmaterial.Informsandmonitorssitesforcorrectstorageconditions;

10.Preparationofallstudybinders;

11.PerformInvestigatorTraining(Compliance&Technicalpart).

12.VerifytheinvestigatorfollowstheapprovedprotocolandallGCPprocedures;

13.Verifyallresearchstaffandfacilitieshaveadequatequalificationsandresourcesremainadequatethroughoutthedurationofthestudy;

14.Keycontactforcommunicationsbetweenthesponsorandtheinvestigator;thepointoffirstcontactwheninvestigators/sitepersonnelenquireaboutpatientinclusion/exclusioncriteriaforongoingtrials;

15.EnsurethatobservationsduringstudiesarecorrectlytrackedandforwardedtotheresponsibledepartmentsinXXXX;

16.Verifythatsourcedata/documentsandothertrialrecordsareaccurate,complete,andmaintained.Regardingtheresultcalculations:ensuretheusabilityofvalidatedcomputerprograms/softwareandresultcalculationincompliancetoapplicableSOPs;17.Communicatedeviationsfromtheprotocol,SOPs,GCP,andtheapplicableregulatoryrequirementstotheinvestigator;

18.Interpretsandevaluatesresultswithrespecttothestudygoalsand,ifnecessary,discusswiththesite,thestudymanager,eg.Interruptionofthestudyorinitiationofadditionalmeasurementsattheexternalsite;

19.Performtroubleshootingforunexpectedresultsaccordingtostudymanagerorprotocol’srequirements;

20.EnsurecompletionandavailabilityofStudyDocumentation,togetherwithStudyManagement;21.Adverseevents,concomitantmedications,andintercurrentillnessesarereportedinaccordancewiththeprotocol;22.ConductStudyClose-outvisitsaccordingtomonitoringplan;

23.EnsureeCRFandWinCAEvarereadyfordatabaselock;

24.ArchiveStudyRecords/Databaseaccordingtoguidelines;

25.Responsibleforpoststudysample/reagents/investigationaluseproducts/instrumentsdispositioncompletedduringtheClose-Outvisit;26.Participationinprojectteams,globalconferencecallsand/ormeetingstoreviewprogressofongoingclinicaltrialsandtoassessdevelopmentofnewprojectsregardingcustomerusability,practicabilityandSOPdevelopment,tocontinuouslyimprovequalityandefficiencyoftheevaluationteamandprocesses;

27.Contributetothecontentofthestudyreportandcontributetopublicationsforjournalsandcongresses.

PossibleAdditionaltasksforSeniorPositionHolders;

28.ResponsibleforInvestigatorSelection(accountabilitylieswithStudyManager)

29.Providementoring,includingtrainingonthejob,tothenewCRAstoensurethattheirroleandcontributionisoptimized.

BasicRequirementsoftheJob

1.Bio-medicalrelatedscientificdegree;canvaryfromabachelor,masterandnursingqualifications;

2.Knowledgeofapplicablestandardsanregulationsforclinicaltrialsandlabconduct(InternationalConferenceonHarmonization/WHOGoodClinicalPracticestandards(ICH-GCP),IVDdirectives,FDAregulations)

3.Practicalexperienceinstudymonitoringaccordingtoglobalstandards(ICH)

4.2-5yearsofClinicallaboratoryexperience;

5.DemonstratedexperienceincomputerskillstoincludeMicrosoftWord,Excel,andbasictemplates;

6.Basicstatisticalknowledge;

7.ProfessionaluseoftheEnglishlanguage;bothwrittenandoral;

8.Openandclearcommunicator;

9.Abilitytomakesounddecisionsandanalyzeandsolveproblems;

10.Conscientiousandprecisedeliveryofworkevenwhenunderpressure