Sophia Chu Email & Phone Number

San Francisco, California, United States

San Francisco, California, United States

Boston, Massachusetts, United States

South San Francisco, CA

• Serve as Study Manager for 5 Phase I and I/II studies spanning indications in oncology and immunology
• Oversee 4+ vendors for Trial Master File and study management/conduct
• Manage study closeout milestones and oversee site closures across 4 countries by regional trial managers, CRAs, Payments, and vendors
• Lead quarterly cross-functional TMF QC reviews for audit-readiness
• Ensure that study milestones are updated and being met by all study stakeholders
• Set and manage expectations and project milestones for vendor management

South San Francisco, CA

• Serve as Lead Global Studies Associate for 7 different Phase I, II, and III oncology studies across several indications and molecules
• Create and maintain project tools and trackers for 9 Global Study Managers and 8 vendors, contract research organizations (CROs), and local affiliates across 25 countries
• Lead weekly global operations meetings with 4 study managers, ensuring team projects are on schedule and coordinating task prioritization
• Manage Clinical Trial Management System (CTMS) project milestone tracking and data quality
• Primary contributor and manager of study level Trial Master File (TMF); initiates and oversees periodic 6-month cross-functional reviews of the TMF

Genentech

• Serve as Clinical Trial Assistant for $3M Bladder Cancer study, Head and Neck Cancer study, Lung Cancer study, and 2 Phase III Breast Cancer studies
• Responsible for monitoring materials to 50+ sites to ensure all sites have the latest safety information
• Perform quality control checks on 700+ documents for clinical trial management
• Update clinical trial management system to enable collaboration between study team and 20+ sites across 15 states and internationally
• Led activation of 5 sites across 5 states in 30 days to meet enrollment deadline

Barton Lab

• Conducted scientific experiments on spleen cells in 400+ mice
• Developed protocols for 20+ lab members for immune response project to analyze commensal binding to B cells in the GI tract for mice
• Presented poster on immunological response in mice to 25+ UC Berkeley faculty in molecular and cellular biology

Barton Lab

• Provided updates to 12 lab researchers and principal investigator regarding the maintenance of lab mouse colony for innate immunity research
• Maintained meticulous records of mouse colony husbandry in 4000+ logs and censuses
• Trained 5 lab workers on mouse colony maintenance
• Updated and tracked census numbers for 5000+ mice
• Offered position as researcher in May 2016