Courtney Smith

• Coordinated global clinical trial supply operations and documentation, supporting Phase III studies from initiation through closure and ensuring compliance with Good Documentation standards.
• Facilitated over 25 global clinical trials ensuring on-time distribution of clinical supplies across diverse global regions. Reduced supply processing times and ensured consistent on-time delivery timelines.
• Served as primary backup for research trial Project Manager for short-term and long-term needs, providing comprehensive project support, resulting in uninterrupted project continuity.
• Collaborated with project managers by communicating project risks, enabling proactive mitigation and uninterrupted trial progress.
• Assisted with administrative tasks that improved departmental efficiency and ensured smooth project operations.
• Maintained vendor, shipment, and supply trackers, ensuring real-time visibility into trial logistics and compliance.
• Administered client communications and scheduling, leading to positive client feedback and strengthening client relationships.
• Guided approvals for essential project documents, maintaining compliance and timely execution of trial activities.
• Prepared meeting agendas and minutes for distribution and record keeping.
• Maintained database and spreadsheets with accurate inventory and status.
• Maintained accurate documentation of all projects, facilitating efficient audits and future reference.
• Managed competing demands and professionally adapted to frequent change, delays and unexpected events.
• Assisted in developing training materials and organized workshops aimed at enhancing skill sets among staff members working under various capacities on different projects within the organization.
• Orchestrated onboarding of new team members, ensuring seamless integration into project workflows and culture.
• Increased stakeholder satisfaction by providing comprehensive weekly project updates and forecasts.

Supported clinical trial operations across multiple therapeutic areas by maintaining Interactive Response Technology (IRT) systems, managing clinical trial documentation, and monitoring budgets, timelines, and compliance.

• Supported 30+ clinical studies across multiple therapeutic areas, ensuring seamless IVRS/IRT system operations and updates.
• Completed periodic trial file reviews to ensure documents were current, accurate, and compliant with regulatory standards.
• Maintained project documentation with high accuracy, strengthening audit readiness and improving compliance ratings.
• Monitored project budgets, team performance, and timelines in Clarity to support on-track study delivery.
• Assisted with onboarding newly hired staff members and coached on task prioritization.

Oversaw procurement processes, vendor relations, and documentation management while driving process improvements and supporting ERP system training initiatives.

• Coordinated procurement operations, including vendor relations, purchase requisitions, and payment processes.
• Documentation and Records Management for departments, including authoring and maintaining corporate SOPs and internal documentation.
• Created process improvement project for procurement requests that streamlined process for entire department of 120 team members.
• Developed ERP training materials, accelerating onboarding processes for new hires by 20%.