Job Description
Objective / Purpose of Role
The Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring, vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study related matters that impact study participant safety, data integrity, study timelines, quality, and budget. The SS will demonstrate a greater level of independence in executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue escalations from CROs and effective relationship management with Key Principal Investigator(s).
Key Activities / Key Responsibilities
1. Develop study specific documentation, as delegated by the Study Manager
2. Contribute to the oversight of country and site feasibility assessment and site selection
3. Oversight of CRO for IRB/EC related submission/approval activities
4. Oversight of essential documents for study life-cycle management
5. Develop/Oversee site and investigator training materials
6. Ensure accurate and timely study entry and updates to ClinicalTrials.gov
7. Process documents for signature in DocuSign
8. Oversight of Clinical Trial Insurance
9. Attend Global Study Operations team, vendor, and/or Cross-Function Study Execution Meeting(s) and take meeting ...