CRAs-Guide-to-Monitoring-Clinical-Research

1Mypursuit手打整理，版权归原作者所有，请勿用于商业用途，转载请注明出处ChapteroneWhatIsaCRA?uringourteachingandworkingwithCRAsovermanyyears,wehavenoticedasurprisingdiversityinwhatCRAssaytheirjobsanddutiesare.Thisisduetothegreatvariationintheirexperienceandintheorganizationsforwhichtheywork.TherearealsomanypeoplewhoarenotCRAs,whowanttogetabetterfeelfortheclinicalresearchprocessbyunderstandingwhatCRAsdoandhowtheydoit.Thepurposeofthischapteristwofold:togivethereaderwhoisalreadyaCRAaportraitofwhatatypicalCRA”lookslike,”andtoprovidenon-CRAreaderswithaquick,concise,descriptionofwhatCRAsareandanoverviewofwhattheydo.TheCRA—AnOverviewTheAcronym“CRA”(ClinicalResearchAssociate)hasevolvedintoacatchalltitleinthepharmaceuticalindustryandhasbecometheuniversaltermforanyoneinvolvedinmonitoringclinicaltrials.MostCRAshaveaBachelor’sorMaster’sdegreeinoneofthenaturalormedicalsciences.However,recenttimeshaveevenseenphysiciansworkingasCRAs,particularlyinEuropeandAsia.CRAscanbefieldmonitorsworkingregionally,ortheycanbebasedin-house.SomeCRAsareemployeesofpharmaceuticalcompaniesdevelopinganewdrugorofcontractresearchorganizations(CROs)hiredbypharmaceuticalcompaniestohelpwithdrugdevelopmentprojects.OtherCRAsworkasindependentcontractorsandmayworkonprojectsforoneormorepharmaceuticalcompaniesand/orCROsatthesametime.AlthoughCRAsperformavarietyofclinicaloperationsandmonitoringactivities,asshowninTable1,traditionallytheyarethepeoplewhovisitandworkwithstudysitesonbehalfofacompanysponsoringtheresearch.TheCRA’smainroleistohelpensureproperstudyconductandthetimelygenerationandcollectionofqualitydata.Today,thereisaneverincreasingnumberofCRAswhoworksuccessfullyasindependentcontractors.Thistrendbeganinthe1980swhenmanycompaniesmadeanefforttostreamlinebusinessandimprovebottomlines.Manyexperienced,knowledgeablepeoplewereletgo,onlytorehiredasindependentcontractors(atsignificantlyhigherratesthantheyweregettingasregularemployees),byboththeirformeremployersandtheirformeremployer’scompetitors.ThistrendislikelytocontinueandwillmakeworkingasaCRAevenmoreinterestingandchallengingintheyearstocome.TheCRAPersonalitySowhattypeofpersonmakesagoodCRA,andwhatarerequiredtobesuccessful?D2Mypursuit手打整理，版权归原作者所有，请勿用于商业用途，转载请注明出处ACRAshouldbesomeonewhoisaself-starterwithgoodinterpersonalrelationshipskills,whoisdetail-orientedandagoodwriterandspeaker.ACRAmustbeself-confident,flexibleandadaptabletoachangingenvironment.Heorshemustbefocused,managetimewellandfollowthroughonproblemsandcommitments.MostCRAsspendasignificantamountoftimeworkingawayfromtheofficewithoutclosesupervision.Itcanbeveryeasytosleepinorgoshopping,orinvolveyourselfinanynumberofotherdiversionswhenyoursupervisorisn’taround.GoodCRAsmaintainthesamedisciplineandworkhabitsontheroadastheydointheoffice.Yearsago,almostalloftheCRAsinthecompanywhereweworkedwereex-regionalsalesmanagers.PeopleinthesepositionswererecruitedandhiredasCRAsbecausefieldexperienceandinterpersonalrelationshipskillwereconsideredofparamountimportance.TheassumptionwasthatitwouldbemucheasiertoteachthesillsnecessarytomonitorclinicaltrialsthantoteachthepersonalskillsnecessarytoworkandinteractsuccessfullywiththevarietyofsituationsandpersonalitiesthataCRAencounterswhenmonitoringclinicaltrials.Theseex-salesfolksweresomeofthebestCRAsintheindustry.Somepeoplearesimplyneverabletodevelopreallygood“peopleskills”Youcanhaveallofthetrainingandknowledgeintheworldregardingtheconductandmonitoringofclinicaltrials,butifyoucannotworkorcommunicatewiththepeopleinvolved,youwon’tbeasuccessfulCRA.Soifyou’reconsideringthisprofession,orifyouarealreadyaCRAandhopetoimproveyourperformance,youmustaskyourself:AmIateamplayer?DoIgetalongwellwithalmosteveryone?Dospeakingandwritingcomeeasilytome?DoIdoanhonestday’swork,inoroutoftheoffice?DoImeetdeadlines?DoIpayattentiontodetails?DoIlisten?DoItravelwell?Domypersonalcommitmentsallowmetotravelwithaclearconscience?Behonestwithyourself.Ifanyofyouranswersareno,youshouldtakeactiontoimprove,orconsideranotherprofession.ThedynamicsoftheworkingrelationshipsbetweentheCRA,thesponsor/CRO,andinvestigativesitesarecomplex.ACRAmustmaintaincurrentinformationoneachsitethatheorsheismonitoring,includingdataonsiteperformance,currentenrollmentstatus,problemresolutionandcorrectionsthatneedtobemadeduringthenextvisit.Tomaintainthisinformation,theCRAmustdependonothersponsorpersonnel-peoplewhomaybestressed,busyandworkingtomeetdeadlines.Ataninvestigativesite,therearesimilarproblems,includingthefactthatyourstudymaynotenjoythesamepriorityatthesitethatitdoesatyourcompany.Consequently,theCRAmustbeabletoactasacheerleaderandcoach,aswellasan“enforcer.”Thesearedifficultrolestoperformallatthesametime.Whetherworkingwithcolleaguesatthehomeofficeorsitepersonnel,theCRAneedstoemployallthesillsmentionedabovetoavoidproblemsandgetthe3Mypursuit手打整理，版权归原作者所有，请勿用于商业用途，转载请注明出处jobdone.CRAsmustbea“JackorJillofalltrades”becausetherearesomanyactivitiesandtasksthattheywillbeinvolvedinifdoingthisjobforanylengthoftime.TheMindsetofaConciergeDuringarecentteachingassignment,Istoppedbytheconciergedeskatthehoteltocheckona