TheClinicalResearchAssociate(CRA)isakeymemberoftheClinicalProjectTeamandisresponsibleformanaginginvestigatorsitesforselectedstudies.IncumbentsmonitorspecifiedsitestoensuredataintegrityandcompliancewithChilternInternationalorClient’sSOPs,ICHGCPandorISO14155,regulatoryrequirementsandtheprojectprotocol.Incumbentsareresponsibleforensuringthatprojectsarecompletedontimeandwithinbudget.

ClinicalResearchAssociate-1(Entry)
1.Prepareandconductsitevisitsincluding(butnotlimitedto):qualificationvisits,initiationvisits,monitoringvisits,motivationalvisits,auditsupportvisits,andclose-outvisitsaccordingtorelevantSOPs,localrequirements,theprotocolandprojectplansaswellasprovidingtimelyandcomprehensivevisitandstatus(i.e.patientrecruitment)reportsundersupervision.
2.CommunicateeffectivelywithChilternProjectTeammembers(i.e.ClinicalTeamLeader,ProjectManagers,SafetyandDataManagement)toensurestudycompletionpercompanyandclientrequirementsandtimelines.
3.Proactivelycommunicatewithstudysitesandfollow-uponallopenissuesinordertomeettheprojecttimelinesunderguidanceoftheprojectteam.Ensurethatallstudy-relateddocumentationistracked,printed,andfiledasrequiredbyChilternSOPs,regulatoryrequirements,andotherprotocols.
4.Toensurethatinvestigatorsitefilesareassembledappropriatelyandthatallrequireddocumentationisinplace,trackedandreconciledonaregularbasisagainsttheTMFfiles.
5.PerformotherdutiesasrequiredbytheDepartmentorProjectTeam.

ClinicalResearchAssociate-2(Experienced)
1.Prepareandconductsitevisitsincluding(butnotlimitedto):qualificationvisits,initiationvisits,monitoringvisits,motivationalvisits,auditsupportvisits,andclose-outvisitsaccordingtorelevantSOPs,localrequirements,theprotocolandprojectplansaswellasprovidingtimelyandcomprehensivevisitandstatus(i.e.patientrecruitment)reports.
2.CommunicateeffectivelywithChilternProjectTeammembers(i.e.ClinicalTeamLeader,ProjectManagers,SafetyandDataManagement)toensurestudycompletionpercompanyandclientrequirementsandtimelines.
3.Proactivelycommunicatewithstudysitesandfollow-uponallopenissuesinordertomeettheprojecttimelines.Ensurethatallstudy-relateddocumentationistracked,printed,andfiledasrequiredbyChilternSOPs,regulatoryrequirements,andotherprotocols.
4.Toensurethatinvestigatorsitefilesareassembledappropriatelyandthatallrequireddocumentationisinplace,trackedandreconciledonaregularbasisagainsttheTMFfiles.
5.MaysupportinmentoringlessexperiencedCRAsonprojectordepartmenttasksandrequirements.
6.PerformotherdutiesasrequiredbytheDepartmentorProjectTeam.

ClinicalResearchAssociate–3(Senior)
1.Prepareandconductsitevisitsincluding(butnotlimitedto):qualificationvisits,initiationvisits,monitoringvisits,motivationalvisits,auditsupportvisits,andclose-outvisitsaccordingtorelevantSOPs,localrequirements,theprotocolandprojectplansaswellasprovidingtimelyandcomprehensivevisitandstatus(i.e.patientrecruitment)reports.
2.CommunicateeffectivelywithChilternProjectTeammembers(i.e.ClinicalTeamLeader,ProjectManagers,SafetyandDataManagement)toensurestudycompletionpercompanyandclientrequirementsandtimelines.Beingapro-activememberinteamcallsandactasarolemodel.MaysupportinthecreationofCRAworkingtoolsbasedontheexperienceontheproject.
3.Proactivelycommunicatewithstudysitesandfollow-uponallopenissuesinordertomeettheprojecttimelines.Ensurethatallstudy-relateddocumentationistracked,printed,andfiledasrequiredbyChilternSOPs,regulatoryrequirements,andotherprotocols.
4.Toensurethatinvestigatorsitefilesareassembledappropriatelyandthatallrequireddocumentationisinplace,trackedandreconciledonaregularbasisagainsttheTMFfiles.
5.MaysupportinmentoringlessexperiencedCRAsonprojectordepartmenttasksandrequirements.
6.MaysupportinconductingqualitycontrolaccompaniedvisitswithCRAslevel1or2.
7.PerformotherdutiesasrequiredbytheDepartmentorProjectTeam.
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