Tina Stavros

• Coordinates functional team members and activities across geographies
• Liaises with project management and sponsors to ensure clinical deliverables are met on timeline, quality, and budget
• Accountable for execution of operational strategy and clinical plan including development of project tools and financial impact assessment
• Implements process improvement initiatives and maintains open communication with internal and external stakeholders

• Led conduct of clinical trials from start-up to closeout across assigned countries per ICH-GCP
• Collaborated with Global Clinical Trial Manager for global study execution
• Managed study risk, TMF completeness, and inspection readiness across multiple countries
• Authored study-specific monitoring plans and mentored new hire RCTMs

• Conducted site qualification, initiation, monitoring, and close-out visits
• Performed source document verification, query resolution, and essential document reconciliation
• Monitored biological sample collection and ensured protocol and GCP compliance

• Monitored five trials and 18 sites concurrently for protocol, regulatory, and GCP compliance
• Independently conducted SIVs, IMVs, and COVs across multiple therapeutic areas
• Served as CRA mentor to newly onboarding associates
• Met all sponsor metrics for data entry, query resolution, TMF submissions, and monitoring plan compliance

• Audited clinical sites nationally for GCP compliance across five Type 1 Diabetes protocols
• Designed and launched the TrialNet Ancillary Study Database, streamlining network access to study information
• Managed operations of two ancillary studies and coordinated specimen shipment to research sites
• Monitored specimen processing across 200+ clinical sites and six contracted laboratories

• Coordinated patient navigation and medical records management
• Conducted quality control assessments of patient charts for Clinical Pathways compliance
• Supported clinical trial enrollment processes