Clinical Trial Start-up SpecialistMilan, Italy
Since February 2015
- 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
procedures of the individual centers where the Clinical Trial is
- 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
- 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
- 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
Pharmacist Muggiò, Province of Monza and Brianza, ItalyFebruary 2013 --- February 2014
providing professional and supportive service to patients and identification of the right medical solution:
- 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, ItalyFebruary 2009 --- March 2010
- 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
- test evaluation, revision and update of medical records
ApproachabilityAttention to detailCollaborationCommunicativeIndependenceKindnessInterest in knowledge
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