Shanon Phillips Email & Phone Number

• Operational support: ensure consistency of implementation of quality standards in the affiliate.
• Process management: ensure affiliate processes are aligned with local and global Roche-GNE SOPs, regulatory requirements and are documented and consistently applied.
• Training: support the delivery of effective training programs for affiliate staff (including in-sourced CRO staff, if applicable) in compliance with global and local requirements.
• Quality Risk Management: implement affiliate Quality Risk Management and Inspection Readiness approaches.
• RBM NA Champion: Support NACCO with embedding of RBM

Collierville, TN

• Responsible for complete site management
• Site feasibility, pre-study, contract/budget development, collected start-up documents, completed study initiation and monitoring visits,
• Educated site personnel regarding EDC system, documented discrepancies per EDC, closed discrepancies per EDC, locked patient CRFs, completed close out visits, trained sites for EDC refresher information

Collierville, TN

• Responsible for accurate and timely monitoring of multidiscipline therapeutic protocols
• Site management, verified study files, drug accountability, ensured adequate clinical supplies, retrieved complete/accurate data to achieve deadlines
• Identified potential investigators for upcoming projects