Senior Clinical Research Associate
Since June 2012
Essential Function : to perform the clinical monitoring aspect of designated projects in accordance with applicable SOPs. Responsibilities include performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, data collection), collecting regulatory documentation (when required), performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines. Responsible for coordinating a moderate to large team or multiple small size protocols as the CRA Coordinator, with minimal to no supervision. Alternatively, take on the role of a CRA Coordinator on smaller projects. Parameters : Comply with Company policies, SOPs and regulatory guidelines. Relationships : Reports To Manager Directly Supervises N/A Provides Work Direction to Project team members as appropriate Works Closely with All project team members External Relationships Investigational sites Clients .
Clinical Research Associate (CRA)
January 2009 --- January 2010
September 2002 --- June 2004
I had the full commercial responsibility including budget management needed to establish our drug as a reference in the market. to build a network of key opinion leaders in these fields, carryng out a large range of activities such as participate in major congresses, organize regional/national advisory boards, define a regional market and business intelligence by gathering information regarding doctor’s needs. to maintain regular contacts with market players as medical societies.
April 1988 --- July 1995
in from Liceo Classico Socrate - Rome in 0
in from University of Rome in 0