Benedetta Dobbs-Licwinko

Clinical Research Support professional offering 18+ years of experience supporting Phase I-IV Research Studies. Strengths include coordination of start-up activities , implementation, and continuing refinement of Document Management process and procedures fully compliant with FDA Regulatory requirements. Proven ability to support Project Management with study budget, Investigator Grant Payments, and management of eTMF/TMF. Extensive knowledge of Global Trials, and Site Feasibility assessments during start-up and maintenance. Well versed with IRB/FDA submissions and approvals across HIPAA, ICH/GCP Guidelines. Authored several SOPs, and working Instructions. Responsible for Vendor Management/oversight and also management of Data Monitoring Committee Review Boards. Extensive knowledge of several EDC, CTMS, QMS, IVRS, eTMF systems, overall knowledge of all aspects needed to conduct a clinical Trial.