- Conduct Study Feasibility Assessment
- Plan and Chair Kickoff Meeting
- Develop Detailed Timeline with Clearly Assigned Responsibilities
- Prepare Project Resource Plan
- Prepare Staff Contact Liso
- Project SOP's
- Track and Report Study Execution Against Agreed Upon Timelines
- Manage Processes Across Functional Groups
- Provide Project Status Reports
- Manage Subject Recruitment/Enrollment Timeline
Review Telephone and Visit Reports
- Communicate with Sponsor via Telephone, e-mail etc.
- Conduct and Provide Minutes of CRO/Sponsor Meetings
- Prepare and Distribute Newsletters
- Conduct Study Close-out Meeting
- Setup Study Master File
- Maintain Study Files
- Audit and Transmit Study Files to Sponsor
