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Experiences

Current Experience

  • sCRA freelance
    Since October 2014

  • sCRA free lance
    Since March 2012

Past Experience

  • Senior Clinical Research Associate (CRA)
    October 2015 --- May 2016
    Full monitoring tasks and respponsibilities

  • Senior Clinical Research Associate (CRA)
    July 2011 --- September 2011

  • CSM
    October 2009 --- August 2011
    CSM (Submissions to Regulatory body· Submissions to Ethic committees·Study start up in Italy· Monitoring clinical trial ·Close out in Italy)

  • Senior Clinical Research Associate (CRA)
    October 2005 --- October 2009
    Full monitoring responsibilities· Study start up in Italy· Monitoring clinical trial· Close out in Italy· Audits

  • s CRA
    September 2005 --- October 2009
    · Study start up in Italy· Monitoring clinical trial · Close out in Italy

  • Senior Clinical Research Associate (CRA)
    February 2005 --- October 2007
    Full monitoring responsibilities· Study start up in Italy·Monitoring clinical trial·Close out in Italy·Audits

  • sCRA /Project leader
    June 2004 --- April 2006
    ·Study start up in Italy·Monitoring clinical trial· Close out in Italy ·Submissions to Regulatory body·Submissions to Ethic committees·CRF draft·Attendance to Invest Meetings

  • Clinical Research Associate (CRA)
    September 1998 --- June 2005
    Full monitoring responsibilities· Study start up in Italy· Monitoring clinical trial· Close out in Italy· Audits

  • Senior Clinical Research Associate (CRA)
    July 2001 --- June 2004
    Full monitoring responsibilities· Study start up in Italy· Monitoring clinical trial· Close out in Italy· Audits

  • Clinical Research Associate (CRA)
    September 1998 --- February 2001
    Full monitoring responsibilities· Study start up in Italy· Monitoring clinical trial· Close out in Italy· Audits

  • Clinical Research Associate (CRA)
    April 1997 --- March 2000
    Full monitoring responsibilities· Study start up in Italy· Monitoring clinical trial· Close out in Italy· Audits

Personality

Self Assessment :
CollaborationCommunicativeEfficiencyIndependenceFlexibilityProblem solving

Knowledge

Self Assessment :
DiabetesAdverse Events (AE)BiologyCancer ResearchCardiologyCardiovascular diseasesClinical DevelopmentClinical monitoringClinical operationsClinical pharmacologyClinical researchClinical Study DesignClinical trial audits and inspectionsClinical trial managementClinical Trial Management System (CTMS)Clinical Trial SuppliesClinical trialsCRFCROeCRFEDCEfficacy trialsEthics submission and approval processGastroenterologyGood Clinical Practice (GCP)ICH guidelinesInfectious diseasesInformed Consent DocumentsInformed Consent ProcessIVRSKnowledge of the drug development processKOL managementoncologyOncology Clinical ResearchOracle ClinicalPatient recruitmentPatient Screening and RecruitmentPharmaceutical DevelopmentPharmaceutical IndustryPharmacovigilancePhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)Serious Adverse Event (SAE)Supervising CRAsTraining
LinkedIn Assessment :
CardiologyEDCOracle ClinicalBiochemistryRheumatologyNeurologyCancerAsthmaGastroenterologyInformTherapeutic AreasCTMSGCPClinical monitoringClinical researchClinical trial managementClinical trialsCROICH-GCPoncologyTherapeutic AreasSOPDiabetesEndocrinologyInfectious diseases

Skills and Expertise

Self Assessment :
Interact with physicians Monitor a clinical studyAdvise on strategyArchive study documentsAssist with site trainingAttend investigator meetingCoach and provide guidance to clinical staff.Collaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConduct maintenance visitsConduct post-marketing surveillance studyConduct the trialEnsure good clinical practice (GCP)Ensure data integrityEthics committee submissionsInitiate clinical trials Verify dataUnderstand protocolsTrain StaffTrain on site staffSupervise clinical monitorsSolve problemsSerious Adverse Event (SAE) ReconciliationSelect sitesSelect investigatorsReview informed consent processReview inclusion criteriaReview exclusion criteriaRespond to audit findings

Education

  • in from Job creation for Clinical Trial Monitor in 1997
  • Biology in Pharmacolgy /Molocular biology from Università degli Studi di Genova in 1991

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Native
English
Professional Proficiency
French
Professional Proficiency

Area / Region

Genova, Italy

Others

Driving License
  • No