·
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)
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