Clinical Research Associate
TheCRAwasresponsibleforsitemonitoring,workingaccordingtocompanySOPsandICH/GCPrequirements.
Coreresponsibilitiesincluded:
- Conductingsitequalification,siteinitiation,routinemonitoringandcloseoutvisits
- TraininginvestigatorsandsitestaffduringSIVsandonstudyupdates
- WorkingwiththeCTMtoaddresssitenoncomplianceandcorrectiveactions
- Supportingsiteswithpatientrecruitmentandscreeningstrategies
- Trackingsiteperformance,includingstartup,enrollment,datacollectionandadverse-eventdocumentation
- PartneringwithCTAs/CRAstocollectandreviewessentialdocumentsandmaintaintheeTMF
- Supportinginvestigatormeetingsandstudy-relatedtraining
- ProvidingEDCandotherongoingstudytrainingtosites
- Managinginvestigationalproductandclinicalsuppliesatassignedsites
- Ensuringappropriatecollection,storageandshipmentoflaboratoryspecimens
- ParticipatinginClinicalTrialTeammeetings
Experiencetheywerelookingfor
- BA/BSinlifesciencesoranursingdegree
- 5+yearsofrelevantclinicalresearch/healthcareexperience
- Atleast2yearsofdirectfield-monitoringexperience
- IndependentmonitoringexperienceacrossPhase1,2and3trials
- Oncologyexperiencehighlypreferred
- KnowledgeofGCP,ICH,21CFR,HIPAAandthedrug-development/approvalprocess
- Abilitytoconductremotemonitoring
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