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Summary

Preparation of all the documentation required to start a clinical trial (communication to the Ethic Committee, Health Authorities etc.) Coordinate feasibility studies Conduct pre-study, study initiation and close out visit Properly maintain the Trial Master File to be audited at any time Collaboration with medical reviewers central and local Prepare the documentation and material needed for the start-up visits of the clinical trial. Organise and carry out the monitoring visits: ensure that the trials are conducted according to local/international requirements (ICH-GCP) Ensure and guarantee the quality of data that the investigator collects. Detect any problems during of the performance of the clinical trial (protocol deviations, delayed timelines, suspicion of fraud, etc.) and propose solutions. Closely interact and supervise CRO’s performance for the study activities contracted out (MDS, Kendle, Bioclinica). Complete check of the CRF consistency, including Pharmacovigilance data Be updated on the most relevant guidelines pertinent to therapeutic area of the assigned studies as well as with legislation related to clinical trials

Experiences

Current Experience

  • Senior Clinical Research Associate
    Since February 2015
    • PNEUMOLOGY A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, trial. pathology Nontuberculous Mycobacterial (NTM) Lung Infections • OPHTALMOLOGY A Phase III, Multicenter, trial in Open-Angled Glaucoma or Ocular Hypertension • ONCOLOGY/HEMATOLOGY: A Phase 2, international, confirmatory multicenter, single-arm to assess the efficacy, safety, and tolerability of an antibody in adult patient with minimal residual disease(MRD) of B- precursor acute lymphoblastic leukemia.

Past Experience

  • Senior Clinical Research Associate
    October 2014 --- February 2015
    Monitoring activities of clinical trials about: • PNEUMOLOGY A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, trial. pathology non-CF bronchiectasis.

  • Senior Clinical Research Associate
    February 2014 --- October 2014
    Monitoring activities of clinical trials about: • ONCOLOGY/HEMATOLOGY: A Phase 2, international, confirmatory multicenter, single-arm to assess the efficacy, safety, and tolerability of an antibody in adult patient with minimal residual disease(MRD) of B- precursor acute lymphoblastic leukemia. • VACCINES A Phase IIIb, international, Open, non-randomized trial to assess the immunogenicity and safety of the influenza vaccine in elderly and young subjects according to EMA regulations

  • Clinical Research Associate (CRA)
    February 2010 --- February 2014
    Monitoring activities of clinical trials about: • ONCOLOGY/HEMATOLOGY: A Phase 2, international, confirmatory multicenter, single-arm to assess the efficacy, safety, and tolerability of an antibody in adult patient with minimal residual disease(MRD) of B- precursor acute lymphoblastic leukemia. • PNEUMOLOGY A Phase 4, international randomized trial for medical and medico-economic evaluation of a home-based disease management program in patients with chronic obstructive pulmonary disease on long term oxygen therapy. • PNEUMOLOGY A Phase III, randomized, Multi-Center, trial in severe Exacerbation of Chronic obstructive pulmonary disease.

  • Clinical Research Associate (CRA)
    January 2009 --- January 2010
    Monitoring activities of clinical trials about: • REUMATOLOGY: A Phase 3, Open label, Multi-Center, Extension Study to evaluate the Safety, Tolerability on osteoporosis Treatment A Phase 3 Double-Blind Multi-Centres Study on masculine osteoporosis.

  • Molecular modelling
    May 2005 --- May 2008
    My scientific activity is fit into the molecular analyses’ frame and into the conjectural pharmacophore’s planning field, testing in particular the affinity theoretically, to capitalize in economic and temporal terms in comparison to the biological test’s execution or X-ray crystallization. Employment of molecular graphics’ methods and three-D geometry’s optimization programs (whether on a molecular mechanics level or quantum mechanics) to study characteristics interactions in protein systems. Employment of proper software for energy’s minimization of structure in protein systems, docking computation, conformational researches, simulation of bio molecule’s molecular dynamics. Use of a fully-integrated protein structure prediction programs of molecular structures in pursuit of defining possible molecular bio-active conformations. Calculus of similarity and chemical diversity’s index to employ in three-D structures’ database research. Database exploration to identify molecules akin to one or more compound of reference, to subject them to a pharmacological screening. Employment of chemometrics methods to investigate possible QSAR models for compounds put through screening. Technique of multivariate analysis and experimental layout in order to classify molecules according to describes tied up a) to the chemical structure and b) to the chemical and physical characteristics, in order to select molecules’ subsets on the basis of similarity and diversity, to assign synthesis priority to specific molecules or libraries. Screening of molecules’ libraries of proprietorship and commercial database on a target of pharmacological interest, through the employment of the suite SCHRODINGER’ software

Knowledge

LinkedIn Assessment :
Clinical trialsXPClinical researchPharmaceutical IndustryClinical monitoringCROBiotechnologyCTMSPharmacovigilanceClinical DevelopmentICH-GCPGCPTherapeutic AreasClinical operationsMedical DevicesSOPEDCProtocolMedical writingGMP

Education

  • Master in Clinical Research Associate from Università degli Studi di Firenze in 2009
  • 2004 in Pharmacy from Sapienza Università di Roma in 2004

Area / Region

Rome, Italy

Others

Driving License
  • No