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Experiences

Current Experience

  • Clinical Trial Start-up Specialist

    Milan, Italy
    Since February 2015

    management of submission of interventional and non-interventional Clinical trials  (General Medicine and oncology studies):

     

    -          verify the submission of application for authorization and the acquisition of copy of the procedures regulating the establishment and functioning of Ethics committees.

    -          prepare and send the application for authorization of the trial to the site, including the contract draft according to the site and sponsor’s standards

    -          prepare the Documentation modified according to the Ethics committee request (e.g patient information and consent form, letter to the gp, answers to Ethics committee criticalities).

    -          manages the collection of the application for partecipation in a study  science)" rel="nofollow">Protocol and Documentation required to request   authorization;

    -          prepares the Documentation for Ethics approval according to the

                   procedures of the individual centers where the Clinical Trial is  

                   conducted;

    -          responsible for the preparation, review and approval of country  

    submission packages in accordance with laws, regulation and other guidelines and ethical standards.

    -          develop and finalize master and country specific information   

            sheet/Informed Consent forms.

    -          review and approve core country patient informed consents for

            Compliance to country requirements and science)" rel="nofollow">Protocol as applicable

    -          prepare the financial agreement/addendum to the financial agreement letter for an external al structure and obtain the sponsor signatures for the shipment to the site

    Management of submission of interventional and non-interventional clinical trials  (General Medicine and Oncology studies):

     

    -          Verify the submission of application for authorization and the acquisition of copy of the procedures regulating the establishment and functioning of Ethics Committees.

    -          Prepare and send the application for authorization of the trial to the Site, including the contract draft according to the Site and Sponsor’s standards

    -          Prepare the documentation modified according to the Ethics Committee request (e.g Patient Information and Consent Form, Letter to the GP, answers to Ethics Committee criticalities).

    -          Manages the collection of the application for partecipation in a study  protocol and documentation required to request   authorization;

    -          Prepares the documentation for ethics approval according to the

                   procedures of the individual centers where the clinical trial is  

                   conducted;

    -          Responsible for the preparation, review and approval of country  

    Submission packages in accordance with laws, regulation and other guidelines and ethical standards.

    -          Develop and finalize Master and country Specific Information   

            sheet/Informed Consent forms.

    -          Review and approve core Country patient informed consents for

            compliance to country requirements and protocol as applicable

    -          Prepare the financial agreement/addendum to the financial agreement letter for an external al structure and obtain the Sponsor signatures for the shipment to the Site

Past Experience

  • Pharmacist Muggiò, Province of Monza and Brianza, Italy

    February 2013 --- February 2014

    providing professional and supportive service to patients and identification of the right medical solution:

    -         accurately dispensing of drugs to patients according to the Doctor prescription. and preparations of personalized drugs.

    -         management of medical equipments for patients, supplementary assistance, drug purchase and distribution on behalf of asl (national sanitary system).

    -         Diagnostic activities (glycemia test, cholesterol, blood pressure test) and evaluation of prescriptions to avoid errors and Verification of their suitability for each patient Treatment.

    -         measuring, Packaging, labelling and recording of medications.

    -         providing information to patients about use of medications, their storage and possible side effects.

    -         ensuring the accuracy of prescriptions, products and services.

    -         developing the Pharmacy electronic discharge system.

    -         managing and resolving complaints.

    -         monitoring of patients under specific therapies.

    -         maintaining Pharmaceutical stock, creating inventories and ordering

  • Clinical Research Associate Assistant Cinisello Balsamo, Metropolitan City of Milan, Italy

    February 2009 --- March 2010

    manage a Clinical Trial study of atherosclerotic Pathology:

    - diagnosis of atherosclerotic patients using ultrasound and echo color-doppler  

      tecniques as flow-mediated dilation (fmd) of the brachial artery and    

      ultrasound b-  mode carotid artery test  measuring the intimately media

     thickness (imt);

    - test evaluation, revision and update of medical records

Personality

Self Assessment :
ApproachabilityAttention to detailCollaborationCommunicativeIndependenceKindnessInterest in knowledge

Education

  • Bachelor in Pharmacy from Università degli Studi di Milano in 2014

Training and Certification

  • Training on the National Monitoring Centre for Clinical Trials and on on procedures and timing of study document table(Sponsor Specific): in 2015 Training
  • License to practice the profession of Pharmacist in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Elementary Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Positions I am interested in:
    Clinical Trial Specialist (CTS)
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Milan, Italy

Others

Driving License
  • No

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