Study Coordinator
CurrentDrafts and distributes protocols and amendments using study outline or client supplied information. Reviews study compliance against protocol, SOP, and regulatory agency guidelines. Participates in the peer review process for scientific reports and collates final products with electronic publishing tools. Reviews QAU report audits with appropriate contributors to ensure that all necessary report/raw data clarifications are completed. Ensures study files are well documented, organized, and up-to-date, including study schedule, protocol, and correspondence. Reviews study schedules based on input from the Study Director (SD) and communicates work plan to laboratory personnel and support groups. Proactively interacts with study team (SDs and operational staff) as primary contact in communication to ensure key milestones are achieved, reviewing progress and study status against initial work plan.
