Experience

Clinical Research Technology

• Medical Practices
• 1 - 100 Employee

• • Feb 2015 - Present

  •Project Management of clinical studies both interventional and observational;•Developing and management of clinical project;•Start-up/Regulatory activities of clinical trials: Phase II-III, observational, cost utility, medical device;•Medical writing: design and review of study tools, documents and processes required for submission to Regulatory Authorities and Ethical Commit; Development of regional patient ICF and other protocol specific documents; •CRA License (from December 2015) in accordance with Decree 15 nov 2011 and monitoring activities (Pre-Study Visit, Site Initiation Visit, Monitoring and Close Out Visit) intended to facilitate and to assure that clinical trials comply with the requirements of the approved study protocol, the approving Ethic Committee and Competent Authority and other regulatory requirements;•Preparation of monitoring reports;•Detection of any problems during of the performance of the clinical trial (protocol deviations, delayed timelines, etc.) and proposition of solutions;•Compilation and execution of contracts with hospitals and pharmaceutical companies;•Drug supplies and drug accountability at study centers;•Management of procedures for collection and shipment of biological samples at the Central Laboratory;•Clinical Data management including CRF (Case Report Form) design;•Management of the progress of studies by tracking regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, and data query generation and resolution;•Pharmacovigilance and safety reporting: notification of AE/SAE;•Participation in meetings and teleconferences with the project team;•Selection of suppliers for necessary services to the management of the trial.Strong analytical and reasoning skills. Excellent written and interpersonal communication skills. Show less

• • Feb 2014 - Feb 2015

  •Establish and maintain the tracking tools for assigned trials;•Create, assemble and coordinate shipping of study materials;•Conduct initial review and tracking of invoices & study payments;•Receive clinical study documents from study team, review for completion, accuracy and expiration, and submit to the TMF;•Generate, review and approve TMF document workflows;•Review TMF inventory for missing and expiring documents;•Support Clinical Document Control Specialist, LCRA and CPM to track and file documents and study metrics;•Support maintenance of the Trial Master File (TMF) and assist in quality control as appropriate;•Review and assist in the collection of essential documents for completeness and compliance with SOPs, the protocol and appropriate regulations;•Distribute clinical trial related materials to sites or clinical team members;•May act as a central contact for designated project communications, correspondence and associated documentation;•Participate in team meetings and assist in preparation of agendas, minutes, and tracking of action items;•Assist CRAs in preparation for clinical trial site monitoring visits;•Assist in the creation of study materials, including but not limited to documents, presentations, and reports;•Perform administrative tasks to support Clinical Operations Department and team members as needed.Strong organizational skills. Show less



CEINGE Biotecnologie Avanzate

• Italy
• Biotechnology
• 100 - 200 Employee

• Research Fellowship at Ceinge

  • Feb 2014 - Feb 2015

  Winner of the competition for the Training Project Biogene LAB-GTP: “Genomics and Bioinformatics specialists support for the development of new technologies and analysis/identification of genes and mechanism of their expression”. Study area: Project management, bioinformatics, algorithms for alignment of biological sequences/Imaging, operating systems, data warehouse, data mining and machine learning, statistics, use of databases, web technologies, molecular biology (nano-biology techniques) and genomic diagnostics. Excellent computer skills and multi-tasking capability. Show less



Università degli Studi di Napoli Federico II

• Italy
• Higher Education
• 700 & Above Employee

• BSc student

  • 2011 - 2013

  Academic degree in Biology cum laude. Main focus: Scientific research in cancer development. Thesis work entitled “Effects of nonylphenol on human endometrial cells”, abstract in review presented at the 67th National Congress of Human Anatomy - Italian Journal of Anatomy and Embryology, M 1122-6714. Strong skills acquisition applied to: Farmacology, toxicology, ematology, immunology, physiology, genetics, microbiology, biochemistry, parasitology. Demonstrated ability to communicate in scientific meetings. Show less