JOB DETAILS

1. Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
2. Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines

3. Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits

4. Prepares and maintains site manuals, reference tools and other documents

5. Maintains, updates, and inputs clinical tracking information into databases

6. Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client

7. Manages shared mailbox, processes site requests and routes corresp...