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TobeaCRA2July2005Tobeinternationallyrecognisedasthepremierorganisationforclinicalresearchrespectedasakeyinfluencer,promotingknowledgeandunderstandingbyengagingthehealthcarecommunityandthegeneralpublic.TheInstituteofClinicalResearchThamesHouse,MerePark,DedmereRoad,Marlow,BuckinghamshireSL71PBinfo@instituteofclinicalresearch.org:01628899766Disclaimer:Theopinionsexpressedinthispublicationarethoseofthesubcommittee,andnotnecessarilythoseofTheInstituteofClinicalResearchAllrightsreserved.Nopartsofthisbookmaybereproducedbyanymeansortransmitted,ortranslatedintomachinelanguagewithoutwrittenpermissionofthepublisher.ISBN0-9549345-4-7DesignedbyStrettonGraphics01628828222TheleadingorganisationforclinicalresearchprofessionalsInternationallyrecognisedasthepremierorganisationforclinicalresearch,respectedasakeyinfluencer,promotingknowledgeandunderstandingbyengagingthehealthcarecommunityandthegeneralpublic.RaisingstandardsTheInstitute’sprofessionalstandardsencourageourmemberstoworktothehigheststandards,enhancingthestandardsofclinicalresearchandmaintainingtheprofessionalidentityofmembersTheInstituterecognisestheacademicachievementandclinicalresearchexperiencebyawardingdesignatoryletterse.g.MICRtoourmembers.SharingknowledgeTheInstituteoffersacomprehensiverangeofInformationServicesandpublications,includingourjournalClinicalResearchfocus,ourpublications,onlineresources,aresourcecentreandmembershiphelpline.DevelopingprofessionalsTheInstituteprovideseducationalcoursesandtrainingworkshops,continuingprofessionaldevelopment,academicqualificationsandaccreditationoftrainingcourses.Alloftheseenhancetheprofessionalcompetenceofourmembers.Formoreinformationcall+441628899755orvisit:•Logical,MethodicalandOrganised?•Approachable,friendlywhilstbeingfirm?Doyou:•Enjoymeetingnewpeople?•Enjoytravelling?•Workingbothaspartofateam,andindependently?Ifso,thenreadonasacareerinclinicalresearchasaClinicalResearchAssociate(CRA)couldbeforyou!AcknowledgementGratefulthanksareextendedtomembersoftheCRASubcommitteepastandpresentfortheirinput.TobeaCRA5July2005Acknowledgement............................................4Isthisyouorcouldthisbeyou?......................................4Contents...................................................5Introduction.................................................7TheClinicalResearchAssociate(CRA).............................8Definition.......................................................8RoleandFunctions................................................8Table1........................................................10EducationandTrainingOpportunities.................................11Qualifications,ExperienceandSkills..................................11Qualifications:..............................................................11Experience:................................................................12EssentialSkillsofaCRAinclude:.............................................12CareerDevelopment..............................................13CRALevelI:................................................................13CRALevelII:...............................................................13CRALevelIIIorSeniorCRA:.................................................14HowdoIfindaCRAPosition?......................................14ContentsTobeaCRA6July2005TheInstituteofClinicalResearchCRASubcommittee.................15Wouldyouliketofindoutmore?...............................16DrugResearchandDevelopment.....................................16PhasesofClinicalResearch.........................................17OrganisingaClinicalTrial..........................................18Conclusions................................................20OrganisationsandWebsites....................................21References.................................................23Glossary...................................................24TobeaCRA7July2005IntroductionAnimportantobjectiveofclinicalresearchistoensurethatmarketeddrugsareassafeandeffectiveaspossible.Whenapromisingdrugisdiscovered,apharmaceuticalcompanywillplanaclinicaldevelopmentprogrammeinvolvingseveralphasesofclinicalresearch.Eachphasewillinvolveatleastoneclinicaltrialortrial,sponsoredbythepharmaceuticalcompanyresponsibleforthedrugtobetested.CRAsareinvolvedinallphasesofclinicalresearchandatallstagesofaparticulartrial.Therefore,possibleCRAdutiesincludemostoftheactivitiesrequiredtosetup,monitorandcompleteaclinicaltrial.AnewCRAismostlikelytobeinvolvedintheinitiation,monitoringandclose-outofaselectedgroupofinvestigationalsites.RecruitmentofCRAsmaybedirectlyintoapharmaceuticalcompanyorintoaContractResearchOrganisation(CRO)whichcanplan,organiseand/orconductclinicaltrialsonbehalfofpharmaceuticalcompanies.Thisbookletaimstoprovideideas,informationandguidancetothosewhomightbeinterestedinbecomingaCRA,ei