BrightOwl Loader Loading

Experiences

Current Experience

  • CRA III


    Since December 2012
    therapeutic experience: circulatory, digestive system/haematology, Diabetes mellitus, genitourinary, infections/parasitic diseases, musculoskeletal, nervous system, oncology, Respiratory, transplants CRA iii: assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study Documentation to ensure good start-up of the investigation sites. performs Training site staff in all study procedures in order to ensure science)" rel="nofollow">Protocol/ich-gcp Compliance. conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of case report form (crf) in Compliance with the science)" rel="nofollow">Protocol, SOP’s and ich-gcp requirements in order to ensure data integrity and subject safety. conducts source data Verification and in house review of Clinical data and ensuring timely resolution of data queries to guarantee reliable Clinical data. manages the investigational products (storage, inventory, dispensing records, Packaging and labeling) and the trial material (Investigator study file (isf), crf, questionnaires, diaries, etc) to ensure timely and correct supply to the site. cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (Adverse Events and adverse reactions such as aes/saes, susars, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues. conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project. is the main contact person for the site in order to ensure close follow up. promptly addresses the project coordinators (pcs)/ project managers (pms) about any issues that can jeopardize the conduct of the Clinical projects assigned. guides and supervises Clinical monitors (cms) in order to Coach and train them on the job. THERAPEUTIC EXPERIENCE: Circulatory, Digestive System/Haematology, Diabetes mellitus, Genitourinary, Infections/Parasitic Diseases, Musculoskeletal, Nervous System, Oncology, Respiratory, Transplants CRA III: Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites. Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance. Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP’s and ICH-GCP requirements in order to ensure data integrity and subject safety. Conducts source data verification and in house review of clinical data and ensuring timely resolution of data queries to guarantee reliable clinical data. Manages the investigational products (storage, inventory, dispensing records, packaging and labeling) and the trial material (Investigator Study File (ISF), CRF, questionnaires, diaries, etc) to ensure timely and correct supply to the site. Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reactions such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues. Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project. Is the main contact person for the site in order to ensure close follow up. Promptly addresses the Project Coordinators (PCs)/ Project Managers (PMs) about any issues that can jeopardize the conduct of the clinical projects assigned. Guides and supervises Clinical Monitors (CMs) in order to coach and train them on the job.

Past Experience

  • Senior Clinical Research Associate (CRA)

    May 2012 --- December 2012
    completed ppd CRA Qualification process for independent monitoring which includes a skills assessment and combination of self study, classroom and field request (june 2012). sr. craii: senior Clinical Research Associate: perform and coordinates assigned aspects of the Clinical monitoring process in accordance with gcps and global sops to assess the safety and efficacy of investigational products and/or Medical Devices. conducts site visits to determine science)" rel="nofollow">Protocol and Regulatory Compliance, and prepares required Documentation. develops collaborative relationship with investigative sites and client company personnel.

  • Clinical Monitor

    June 2008 --- May 2012
    assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study Documentation to ensure good start-up of the investigation sites. performs Training site staff in all study procedures in order to ensure science)" rel="nofollow">Protocol/ich-gcp Compliance. conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of case report form (crf) in Compliance with the science)" rel="nofollow">Protocol, SOP’s and ich-gcp requirements in order to ensure data integrity and subject safety. conducts source data Verification and in house review of Clinical data and ensuring timely resolution of data queries to guarantee reliable Clinical data. manages the investigational products (storage, inventory, dispensing records, Packaging and labeling) and the trial material (Investigator study file (isf), crf, questionnaires, diaries, etc) to ensure timely and correct supply to the site. cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (Adverse Events and adverse reactions such as aes/saes, susars, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues. conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project. is the main contact person for the site in order to ensure close follow up. promptly addresses the project coordinators (pcs)/ project managers (pms) about any issues that can jeopardize the conduct of the Clinical projects assigned. guides and supervises Clinical monitors (cms) in order to Coach and train them on the job.

  • Senior CRA freelance

    December 2004 --- June 2008
    conduct site Qualification, initiation, Interim monitoring and study close out visits for phase 1-4 studies in accordance with good Clinical practices, ICH guidelines, and standard operating procedures and Business Processes.

  • CRA freelance

    June 2004 --- December 2006
    perform pre study site visits, study start up, Clinical Trial initiation, monitoring and close out activities in accordance with regulations and SOP’s.

  • Clinical Research Associate (CRA)

    February 2002 --- June 2004
    perform pre study site visits, study start up, Clinical Trial initiation, monitoring and close out activities in accordance with regulations and SOP’s.

  • Pharmacist

    October 2001 --- February 2002

Knowledge

LinkedIn Assessment :
Industria FarmacCROBuona pratica clinicaSperimentazioni clinicheCTMSICH-GCPSOPMonitoraggio clinicoSviluppo clinicoOncologRegulatory submissionsFeasibilityCRA qualified to perform monitoring activities independently according to the ItCOMPUTER/TECHNICAL SPECIFIC COMPETENCESTRAININGS AND COURSESRicerca clinicaProtocolloBiotecnolog

Education

  • Laurea in Chimica e Tecnologie Farmaceutiche in from Università dedli studi di Bologna in 0000

Training and Certification

  • CRA qualified to perform monitoring activities independently according to the Italian regulations in 0000 Certification

Area / Region

Italy

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in Italy

Other similar Candidates in this location (country / city)

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like