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Research Assistant
- Perform routine site visits, including pre-study, initiation, interim and closeout visits. Performs responsibilities with minimal support from management. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements, and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
- Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
- Report to project team and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.
- Maintain project tracking system of subject and site information.
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