Project Management
- Conduct Study Feasibility Assessment
- Plan and Chair Kick-off Meeting
- Develop Detailed and Realistic Project Timeline with Clearly Assigned Responsibilities
- Prepare Project Resource Plan
- Prepare Project Staff Contact List
- Project Standard Operating Procedures (SOPs)
- Overall Set-up and Management of the Project Trial Master File (TMF)
- Overall Management of Site Monitoring and Associated Documentation
- Overall Management of Study from Study Initiation through Close-Out
- Ensure compliance with Regulatory Requirements and Good Clinical Practices
- Manage Subject Recruitment/Enrollment Timeline
- Track and Report Study Execution Against Agreed Upon Timeline
- Track the Status of Study Data, Milestones, Deliverables and Budgets
- Serve as a Liaison for Sponsor, Investigators and Project Team Members
- Manage Processes Across Functional Groups
- Provide Project Status Reports
- Review Telephone and Visit Reports
- Communicate Trial Progress to Sponsor via Project Team Meetings, Telephone, e-mail
- Conduct and Provide Minutes of CRO/Sponsor Project Team Meetings
- Prepare and Distribute Newsletters
- Audit and Transmit Study Files to Sponsor
