Senior Clinical Trials Associate
CurrentManaged early-phase clinical trials in oncology, respiratory, nephrology, and medical devices from initiation to closure, including a global Phase 3 infectious disease trial.Supported operational activities related to site evaluation, activation, initiation, monitoring, and close-out, ensuring compliance with study timelines and GCP.Oversaw site selection, feasibility assessments, and budget negotiations for global trials, acting as the main point of contact for clinical sites to ensure protocol adherence and timely trial execution.Conducted regular site calls to ensure sites are on track and promptly addressed issues.Assisted with study site activation activities, including registering investigator sites and collaborating to complete essential documents such as Investigator Initiation Packages (IIP) and study contracts.Managed the electronic Trial Master File (eTMF) for audit readiness and document accuracy, enhancing clinical trial efficiency by leveraging advanced proficiency in electronic spreadsheet management for budget tracking and site activation documentation.Assisted sites in data query management and supported CRAs with site visits, training, documentation, and expense management.Facilitated regulatory submissions, ensuring compliance with timelines and securing timely approvals.Monitored study timelines, tracked milestones, and coordinated cross-functional team communication.Managed vendors for clinical supplies, including shipments, inventory, and reconciliations.Assisted with budget tracking, invoice processing, and Change Order management for out-of-scope activities.Conducted quality control of study files and prepared for audits to ensure compliance.Maintained meeting agendas, minutes, and action items, presenting trial updates to sponsors.Collaborated with data management to ensure accurate data collection and documentation of deviations.
