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1. Review and negotiate site regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.
2. Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
3. Review and provide feedback to management on site performance metrics.
4. Serve as contact for investigative sites, designated project reports, communications, and customer service.
5. Resolve site issues and determine status for product shipment.
6. Work with regulatory team members or sponsor to secure authorization of regulatory documents.
7. Work with legal team members or sponsor to secure authorization of contracts.
8. Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
9. Inform team members of completion of regulatory and contractual documents for individual sites.
10. Work with team members in preparation of regulatory submissions per work instructions.
11. May serve as a SSU Team Lead for country or region as needed. Coordinate activities for projects within area of specialization.
12.May translate or review completed translations of critical documents.
13. May participate in feasibility and/or site identification activities.

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