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Summary

Freelance Clinical Research Associate since 1999 to present. Trial Managed: observational and drug development. Therapeutic Areas Experienced: Oncology (Pulmonary, Breast and other tumours-Melanoma).Phase II-III. Besides anaemia, nausea and vomit in oncology disease).Observational-Phase II-III. Transplant (heart and Kidney).Phase II. Intensive care.Phase II-III. First AID.Phase III. Gastric Disease. Phase II-III. Cardiovascular Disease and Tromboembolism event. Observational -Phase II-III-IV. Infection Disease (HIV- Hepatites).Phase II-III. Respiratory Disease (Bronchitis,Asthma and Asthma in pediatrics).Phase II-III. Obesity.Phase II-III. Diabetes.Phase I- II-III-IV. Skin disease. Phase II-III. Gyneacologic disease.Phase II-III. Urology : infection disease, Disfunction Erectile. Phase II-III. Psychiatry Disease :Schizoprenia-Depression.Phase II-III. Neuropsychiatry:Alzheimer's Disease. Phase II-III. Since 1999: Training on Protocol, specific Sop and Procedures for each monitored and Clinical Trial.

Experiences

Current Experience

  • Senior Clinical Research Associate
    Since January 1999
    Senior Clinical Research Associate in accordance with ICH-GCP Guidelines and relevant SOPs , experienced in: -Study specific procedures and regulations; -Site Management: Coduction of the fesibilities-Site Selection-Start up- Initiation Visit-Monitorig -Close out Visit ; both remote activities and site visits. Over 200 clinical trials managed across over 300 sites and over 1000 visits performed on sites (until October 2014).. -Ability to work with and lead a project team. -Ability to resolve project related problems and prioritizes workload for self and team. -Ability to support, train and supervise junior staff. -Ability to work independently from a home office location

Past Experience

  • Clinical research associate ( Senior)
    January 2009 --- October 2014
    sCRA (free-lance/ Co-source Merck Sharp Dohme) (07/JAN/2009-30/SEP/ 2014) - Conduction of feasibilities - Investigator selection - Full trial site responsibility - Monitoring - Acting as a local client contact for all trial-related matters

  • Clinical research associate ( Senior)
    January 2007 --- January 2009
    sCRA (free-lance) (since Jun 2007 to 2009 ) - Monitoring - Acting as a local client contact for all trial-related matters

  • Clinical research associate ( Senior)
    January 2007 --- January 2008
    sCRA (free-lance/ Co-source Merck Sharp Dohme) (Dec /2008-Dec 2009) - Conduction of feasibilities - Investigator selection - Full trial site responsibility - Monitoring - Acting as a local client contact for all trial-related matters

  • Clinical Research Associate (Senior)
    January 2004 --- January 2008
    sCRA (free-lance)( March 2004- Dec 2008) -Monitoring -Acting as a local client contact for all trial-related matters

  • Clinical research associate ( Senior)
    January 2002 --- January 2008
    sCRA ( free-lance) Since Sep 2002 -Apr 2008 - Conduction of feasibilities - Investigator selection - Preparation of regulatory /ethic submission - Full trial site responsibility - Monitoring - Acting as a local client contact for all trial-related matters

  • Clinical Research Associate (CRA)
    January 1999 --- January 2007
    sCraand Cra ( free-lance) Nov 1999- dec 2007 - Monitoring - Acting as a local client contact for all trial-related matters

  • Clinical Research Associate (Senior)
    January 2004 --- January 2005
    sCRA ( free-lance) ( Nov 2004- Sep 2005) - Monitoring - Acting as a local client contact for all trial-related matters

  • Clinical Research Associate (CRA)
    January 2001 --- January 2003
    CRA ( free-lance) Jan 2001- Dec 2003 - Monitoring - Acting as a local client contact for all trial-related matters

  • Clinical Research Associate (CRA)
    January 2001 --- January 2003
    CRA (free-lance) (March 2001- may 2003) -Monitoring -Acting as a local client contact for all trial-related matters

  • Clinical Research Associate (CRA)
    January 2000 --- January 2003
    CRA (free-lance) Nov 2000- Dec 2003 - Monitoring - Acting as a local client contact for all trial-related matters

  • Clinical Research Associate (CRA)
    January 2000 --- January 2001
    Cra (free-lance) Sep 2000- Dec 2001 -Monitoring -Acting as a local client contact for all trial-related matters

  • -Consultan -
    December 1998 --- December 1999
    -Consultan -Techno Scientific Aspects in The Nutritional Field

  • Teacher
    September 1996 --- December 1999
    Teacher : Pharmacology -Pharmaceutical Chemistry- Inorganic -Organic Chemistry.

  • Clinical Research Associate (Junior)
    June 1999 --- June 1999
    Junior Monitor Stage Jun 1999

  • Pharmacist
    March 1997 --- November 1997
    Responsible of the Galenic Product Preparation

  • Pharmacist
    March 1996 --- December 1996
    Junior Pharmacist

  • Teacher
    July 1996 --- July 1996
    -Member of the examination Board

  • Internal Student at the Department Phatmaceutical and ToxicologyChemistry and Pharmacology
    November 1994 --- March 1996
    - Experimental Thesis Management .

Knowledge

LinkedIn Assessment :
CROClinical DevelopmentBuona pratica clinicaSperimentazioni clinicheSOPCTMSIndustria FarmacéuticaRegulatory submissionsICH-GCPMonitoraggio clinicooncologyeCRFeTMFSpectrumCo-monitoring visit activities

Education

  • Master Development and regulatory Drug procedures in GCP and GMP in from Master Development and regulatory Drug procedures in GCP and GMP (Tecnofarmaci Association)-Italy in 1999
  • in " Analisi Farmaceutica" -Advance Course from Chemistry Society - Portoferraio-Italy in 1998
  • Abilitation to Pharmacist profession in from Abilitation to Pharmacist profession-Università Federico II Napoli -Itlay in 1998
  • Master's degree Farmacologia in from Master's Degree Farmacologia-Università Federico II -Napoli -Italy in 1998
  • Chimica e Tecnologia Farmaceutiche's Degree- Napoli-Italy in from Chimica e tecnologie Farmaceutiche's Degree - Università Federico II -Napoli in 1996

Languages

BrightOwl Assessment:
Self Assessment:
Italian
Native
English
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Clinical Research Consultant
  • Locations I am interested in:
    Naples, Italy
  • Work From Home:
    Yes, 5 to 0 days per week
  • Work Regime:
    BrightOwl freelancer :     from 4 to 6 Hours per week
  • International:
    Yes

Area / Region

Naples, Italy

Others

Driving License
  • Yes