Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit & non-visit contact reports.
Ensure by monitoring activities that:
Data generated at site are complete, accurate and unbiased.
Subjects’ right, safety and well-being are protected.
Perform clinical study site management/monitoring activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, protocol, Site Monitoring Plan and associated documents.
Coordinate and manage various tasks in collaboration with other sponsor roles.
Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
Identify and assess site performance, quality or compliance problems in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed.
Manage and maintain clinical trial systems such as CTMS, eTMF, etc.
Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team.
Follow the country strategy defined by Country Director.
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