Throughout my career, I have consistently ensured compliance with regulatory guidelines such as FDA and EMA regulations. I have successfully managed multiple trials that adhered strictly to these guidelines, ensuring data integrity and participant safety. My role involved detailed documentation review, site visits, and regular communication with regulatory bodies to address any queries promptly.

When encountering discrepancies or non-compliance, I prioritize immediate action to mitigate risks. I conduct thorough investigations, document findings, and collaborate with the study team to develop corrective actions. Regular follow-ups ensure that the issues are resolved and do not recur, maintaining the study's integrity and timeline.

Effective communication with study sites involves regular, clear, and proactive interactions. I schedule frequent check-ins, provide detailed training sessions, and maintain open lines of communication. Using a combination of email, phone calls, and on-site visits, I ensure that all site personnel are well-informed and supported throughout the study.

I prioritize tasks based on urgency and impact on the study. Using tools like Gantt charts and task management software, I organize my schedule to focus on high-priority activities such as site visits and critical data reviews. I also ensure flexibility to address emergent issues promptly, maintaining the study's progress without compromising quality.

In a previous role, I encountered a significant delay due to a site's non-compliance with data collection protocols. I conducted an on-site review, identified the root causes, and provided tailored training to the site staff. By establishing a more rigorous monitoring schedule and enhancing communication, we were able to get the trial back on track without compromising the data quality.