·  Preparation and coordination of study start-up activities

·  Experience as site contract analyst, site contract negotiations

·  Preparation and management of Ethics Committee and regulatory submissions

·  Feasibility and perform Pre study Visits of Investigational sites

·  Perform Site Monitoring, Initiation and Close Out Visits

·  Audit preparation and follow up

·  Quality control of Trial Master File

·  Experience in several e-CRFs Systems

·  Patient recruitment strategy support

·  Mentoring of junior CRAs, oversight, conduction Co-monitoring visit, review reports

·  Manage operational and technical aspects of projects, establish study milesones

·  Provide operational input into protocol and other study related documents

·  Work closely with vendors (CRO, Laboratories, EDC, IXRS)