Clinical Research Associate (CRA)
Since December 2014
Duties and Responsibilities: Coordination of the clinical trials in Europe and US in accordance with European and FDA requirements and guidelines. Managing of the clinical study life-cycle: budget discussion and allocation, study set up, selection of sites, management and training of study the site personnel (including investigators and coordinators), planning and oversight of national and international study meetings. Project management of clinical studies assigned to CROs conduction. Preparing and completing critical study documents (protocol; synopsis; flowchart; informed consent template; investigator brochure; monitoring guideline; consultant agreements; clinical study worksheets; etc.). Establishing timeline and target dates for completion of study milestones in collaboration with trial leadership. Assuring that all clinical site trial documentation are maintained in compliance with all applicable guidelines and corresponding procedures documents.
Clinical Research Monitor
Since June 2012
Responsible for: taking part in developing study design and protocols; setting up, organizing and monitoring clinical trials; taking care of study compliance according to GCP; preparing and submitting documentation to Competent Authorities and Ethics Committee; staff training data analysis and drawing up of reports; analysing clinical data and writing clinical reports; control of study budget and timelines; organizing Investigators Meetings; collaborating to the Medical Department start-up; strongly involved in cross-functional work with R&D, Regulatory Affairs, and Sales&Marketing, to optimise products support.
January 2012 --- May 2012
Main activities: Create a new subsidiary for new markets opportunity, Find new potential customers, Managment of relationships with suppliers and customers, especially in France and Slovenia, Start a new web-market activity.
October 2011 --- January 2012
Responsible for: researching how the body's functions are affected by nutrient supply; investigating the relationship between genes and nutrients; studying how diet affects metabolism; examining the process of nourishment and the association between diet, disease and health; providing health advice and promoting healthy eating; advising about special diets; educating people about nutrition;
September 2010 --- April 2011
Project: Development of a new medical product for advanced therapies (ATMPs) in VivaBioCell SpA. Product: Autologous Small Bone Fragment (ASBF) composed by a 3D biodegradable PCL scaffold (produced with the micro molding technique) and autologous cells isolated from the bone marrow. Resposible for: Developing the steps necessary to obtain the authorization to market introduction: - Request for micro-small-medium-sized enterprises (SME) for VivaBioCell SpA, - Request of the Regulatory advice to the ITF (Innovative Task Force) EMA, - Request to the CAT (Commission for the advanced therapies) for a Scientific recommendation for the classification of the ATMPs - Starting of the certification procedure of quality and non-clinical data. Studying new European laws (Reg. 1394/2007/EC) Developing ideas for application of research outcomes; deciding on research programmes and methodologies in collaboration with the team; generating and pursuing independent and original research ideas to promote research projects and income; assessing, interpreting and evaluating outcomes of research; developing research networks locally, nationally and internationally in support of the research programme; taking part in knowledge-transfer activities, including collaborative meetings with other research groups; maintaining knowledge and understanding within the field/specialism, transforming and applying knowledge acquired from scholarship to research.
November 2007 --- October 2008
Area: Adipose derived Human stem cells and tissue regeneration Project: In vitro isolation, in vitro characterization of human multipotent stem cells from adipose tissue, hAT-MASCs (human adipose tissue multipotent adult stem cells) differentiated into myocites. Evaluation of the differentiation with: Immunofluorescence stayning, Intracellular Ca++ transient with FLUO-4, Electrophysiological parameters. Injection of the hAT-MASCs in an animal model KO for collagen type VI (model for two types of human dystrophies). Evaluation of the presence of the hAT-MASCs in mice tissues with: Immunofluorescence stayning, FISH (fluorescent in situ hybridization) Resposible for: developing ideas for application of research outcomes; deciding on research programmes and methodologies in collaboration with the team; generating and pursuing independent and original research ideas to promote research projects and income; assessing, interpreting and evaluating outcomes of research; developing research networks locally, nationally and internationally in support of the research programme; taking part in knowledge-transfer activities, including collaborative meetings with other research groups; maintaining knowledge and understanding within the field/specialism, transforming and applying knowledge acquired from scholarship to research.
Good Clinical Practice (GCP)21 CFR Part 11FDAUnderstanding of regulatory guidelinesStatistical Data AnalysisUnderstand how results translate to practiceStart-ups
Skills and Expertise
Monitor a clinical studyAssist study siteCreate study documentsArchive study documentsDevelop study timelinesDistribute study documentsDevelop study budgetProvide study site fileManage study budgetAttend at steering committee meetingsAttend investigator meetingAttend seminars, courses and meetings within and outside the companyOrganise meetingsPlan work to meet objectives and deadlines
Junior Clinical Research Associate in from ECCRT European Centre for Clinical Research Training in 2012
Biotecnologie Mediche in Medicina e chirurgia from Università degli Studi di Udine in 2011
Laurea triennale in Biotecnologie mediche in Medicina e chirurgia from Università degli Studi di Udine in 2008
in from FDA Requirement for clinical trials - Donawa Lifescience Consulting in 0
in from Biostatistics for Non-Statistics Cros-NT Academy in 0