Specialist Study Start Up & Regulatory Affairs

📋 Description

• Under guidance of senior team members, independently manages study start-up activities for projects
• Prepare, collect, review regulatory information to support submissions to national authorities and
• Collect, review for completeness and compliance, and track essential documents for Study Start-Up
• Responsible for drafting, negotiating, finalizing, and executing clinical site agreements
• Responsible for site outreach in assigned country/countries; point of contact for site, sharing of
• Coordinate with study teams, sponsors, clinical monitoring, clinical contracts and/or other