Clinical Research Associate (CRA) Rome, Italy
Since December 2014
Outsourced CRA in Novo Nordisk S.p.A.
Part of the Clinical Operations Unit within Project Delivery, working operationally as a member of the Study Team and responsible for the initiation, monitoring and termination of tasks during the study process, according to company policies, SOPs and regulatory requirements.
Clinical Research Associate (CRA)
February 2014 --- November 2014
responsable to monitor clinical trials assuring the protection of the rights, safety and well being of human study subjects, additionally to make certain that the scientific integrity of the data collected in the clinical trials is protected and verified and to assure that adverse events are correctly documented and reported.
Clinical Research Coordinator
April 2011 --- November 2014
responsible of conducting clinical trials according to good clinical practice (GCP) in collaboration with Principal Investigator, Co-Investigator and the Clinical Study Staff. The responsibilities include: subject recruitment, patient care, adverse event reporting, submitting CRFs and other data to the Sponsor as required, study close-out, relating with Ethics Committee, managing all calendars related to the trial, administering study-drugs.
Master's degree in Medical Biotechnology from Università degli Studi di Napoli 'Federico II' in 2010
Bachelor's degree in Biotechnology from Università degli Studi di Napoli 'Federico II' in 2008
Training and Certification
Certification to clinical monitoring activities in accordance with the Ministerial Decree 15 November 2011 (OJ No. 11 of 14 January 2012) in 2013 Certification