Clinical Monitoring

My journey in clinical monitoring began with an in-depth focus on trial master files and investigational site files. Serving as an in-house Clinical Research Associate at Advanced Clinical and Aptinyx, I gained a comprehensive understanding of the various systems in place and their purposes. This experience paved the way for co-monitoring activities alongside field-based Clinical Research Associates, starting with reviews of site investigator files. Gradually, I expanded my expertise to encompass all aspects of clinical monitoring. This includes source document review, Source Data Verification (SDV), Investigational Product (IP) accountability, safety reviews, investigator oversight, and assessing site capabilities.

Since my initial foray into the role of a Clinical Research Associate eight years ago, I have significantly improved my effectiveness as a study monitor. My success in monitoring is largely attributed to my communication skills. Through empathetic and transparent communication, I provide value to the work completed by the site while balancing the goals of the sponsor with the capabilities of the site staff.

Beyond my ability to communicate effectively, I consistently meet clinical study goals and timelines through diligent time and task management. This approach has been crucial in managing large, complex, and challenging studies. One of the most significant challenges is addressing the resourcing needs to meet study timelines, whether dealing with high-enrolling sites, inexperienced staff, or data backlogs. My knowledge and experience equip me to offer personalized strategies that ensure successful outcomes for all stakeholders involved.