ICON plcOperational Compliance Associate II
Jul. 2022 - Jun. 2024During my time as an Operational Compliance Associate at ICON, I independently monitored six clinical research sites across the UK, ensuring adherence to Good Clinical Practice (GCP) and compliance with study protocols. I supervised junior associates, acted as the primary liaison between investigators and sponsors, and contributed to site selection and start-up activities. My role involved conducting root cause analyses, implementing preventative actions, and ensuring data accuracy and protocol compliance during monitoring visits. I also led internal audits, supported external regulatory inspections, and drove continuous improvement in compliance and operational quality. Additionally, I managed site file reconciliation by reviewing essential and non-essential documents for content, consistency, and regulatory compliance with ICH guidelines, project SOPs, and sponsor requirements. I ensured data accuracy through timely query resolution, monitored subject safety and adverse event reporting to sponsors and ethics committees, and maintained compliance with drug accountability and storage requirements.