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Experiences

Current Experience

  • Clinical Research Associate (CRA) Rome, Italy
    Since April 2015

    • Activities of Clinical Research Associate;
    • Start-up;
    • Submission;
    • Regulatory Affair;
    • Medical Writing;
    • Approval request for clinical study. 

  • Clinical Research Associate (CRA)
    Since April 2015

Past Experience

  • Clinical Research Associate (CRA) Salerno, Italy
    September 2014 --- March 2015

    • Clinical Research Associate Trainee;
    • Activities of Clinical Research Associate;
    • Certifed CRA according of November 15, 2011.

  • Pharmacist Rome, Italy
    January 2014 --- March 2015

    • Ensure continual compliance with all regional and national rules and regulations;
    • Work with other members of the Pharmacy to ensure accuracy of prescriptions;
    • Ensure that every customer receives friendly, knowledgeable, and efficient service;
    • Experienced in maintaining administrative records such as pharmacy files and in providing excellent customer care by accurately dispensing prescribed medications by calculating, weighing, measuring and mixing ingredients;
    • Able to advise patients on medication brands, medication storage, medical equipment and health-care supplies;
    • Accurately dispensing drugs to patients according to a doctor's prescription;
    • Checking prescriptions for errors and making sure they are appropriate for patients;
    • Contacting and working closely with other healthcare professionals;
    • Managing and resolving complaints;
    • Talking to regular patients to see how their treatment is going;
    • Communicating with customers sympathetically and supportively.

  • Stage come Clinical Research Associate
    September 2014 --- March 2015

  • Pharmacist
    January 2014 --- August 2014

  • Pharmacist Roma, Italy
    January 2013 --- December 2013

  • Pharmacist
    July 2013 --- January 2013
    Farmacista collaboratore

  • Pharmacist Rome, Italy
    May 2012 --- October 2012

  • Pharmacist
    May 2009 --- May 2012
    Farmacista collaboratore

  • Pharmacist Rome, Italy
    May 2009 --- April 2012

  • Pharmacist Rome, Italy
    December 2008 --- April 2009

  • Pharmacist
    December 2008 --- April 2009
    Farmacista collaboratore

  • Pharmacist Rome, Italy
    September 2008 --- November 2008

  • Pharmacist
    September 2008 --- November 2008
    Farmacista collaboratore

  • Pharmacist Roma, Italy
    April 2008 --- August 2008

    Pharmacist Trainee

  • Pharmacist
    April 2008 --- August 2008
    Farmacista collaboratore

Personality

Self Assessment :
OrganizationAnalytical thinkingInnovative thinkingProblem solvingStrategic thinkingCritical thinking

Knowledge

Self Assessment :
Drug safety assessmentActions and modes of action of drugs in the human speciesDrug Safety and PharmacovigilanceEfficacy trials Scientific writingMedical affairsFamily practiceInfectious diseasesInflammationInformed Consent ProcessKnowledge of the drug development processMicrosoft ExcelMicrosoft OfficePatient Follow UpPhases of clinical development (phase I to IV)Principles and ethics of clinical researchRegulatory affairsSafety concerns (such as therapeutic ratio with respect to possible adverse effects)Understand levels of research evidenceSafety trialsScientific Writing
LinkedIn Assessment :
Clinical monitoringPharmacyClinical trialsSperimentazioni clinicheRicerca clinicaIndustria FarmacéuticaFarmaciaMonitoraggio clinicoVendite farmaceutiche

Skills and Expertise

Self Assessment :
Build and manage the Trial Master File (TMF) Control data Develop clinical trial protocols Monitor a clinical studyAdverse event reportingArchive study documentsAssess adverse reactions Interact with physiciansApprove monitoring reportsCollaborate with medical teamCollaborate with principal investigatorCollaborate with project teamCollect patient forms and questionnairesCommunicate with investigatorContract approvalControl dataCoordinate with the ethics commiteeData verificationDesign clinical trialEnsure data integrityEnsure good clinical practice (GCP)Ethics committee applicationEvaluate impurity identificationGastrointestinal diseasesGeneral office managementGenerate regulatory submissions Manage clinical trial files/documentsManage trial master file (TMF)Monitor a clinical studyMonitor clinical trials Monitoring subject compliancePrepare regulatory documentsRegulatory documentationRegulatory submissionsSerious Adverse Event (SAE) Reconciliation

Education

  • Master in Pharmacy from "Tor Vergata" University in 2014
  • MASTER DI II LIVELLO in ASPETTI ETICI, REGOLATORI E METODOLOGICI DELLA SPERIMENTAZIONE CLINICA from Università degli Studi di Roma " Tor Vergata" in 2014
  • MASTER DI II LIVELLO in FITOTERAPIA from Università degli Studi di Roma 'La Sapienza' in 2009
  • Bachelor in Pharmacy from "SAPIENZA " University in 2008
  • Laurea Specialistica in Farmacia in Farmacia from Università degli Studi di Roma 'La Sapienza' in 2008
  • Master in Pharmacy from "SAPIENZA " University in 2008

Training and Certification

  • Case Report Form in 2015 Training
  • Regulation n.536/2014 of the European Parlament and Council in 2015 Training
  • Regulation n.536/2014 of the European Parlament and Council, critical issues and opportunities in 2015 Training
  • The role of the CRO in Clinical Trials in 2015 Training
  • Board of Pharmacy of Rome in 2009 Certification
  • Qualified to practice as a Pharmacist in 2008 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Full Proficiency
English
Professional Proficiency

Work Preferences

  • Notice Period:
    13 weeks
  • Positions I am interested in:
    Clinical Research Associate (CRA) Pharmacist Regulatory Affairs Associate
  • Locations I am interested in:
    Belgium Germany Holland Italy Sweden United Kingdom
  • Work From Home:
    Yes, 5 to 0 days per week
  • International:
    Yes

Area / Region

Rome, Italy

Others

Driving License
  • Yes