Associate Site Management Lead
Since October 2015
Coordinates sites including start-up activities, covering all countries for the selected study, Tracks all Ethic Approvals and all CRA activities, Reviews protocol and assists with case report form design, develops study monitoring plans for assigned studies, documents site-specific monitoring visit plans and reports, participates in completion of study related documents,tracks and reports study site progress, mentors less experienced Clinical Research Associates, attends and participates in investigator and study coordinator meetings, coordinates resources, trainings and CRA activities among a team of remote CRA resources.
Senior Clinical Research Associate
Since March 2006
Key Responsibilities: Selection Visit, Initiation visits, Monitoring visits & SDV Inspections, Delivery of GCP training's, Closure visits, Query resolution, Collection of regulatory packages, Submissions to Ethic committees, Drug accountability, Management of SAE, Re- labelling process
March 2005 --- December 2005
Key Responsibilities: Scientific information on pharmaceutical products (urology
November 2003 --- February 2005
Research fellowship at University of Bologna, Dept. Pharmacology of Bologna. To study the effects of delta-9-tetrahydrocannabinol treatment on nociceptin/orphanin receptor (NOP) gene expression in SH-SY5Y neuroblastoma cell line.
Pharnacist; Bachelor Degree; High School Degree in Pharmaceutical Chemistry and Technology from University of Bologna in 2005
Training and Certification
Good Clinical Practice for Clinical Trials Certification