I have extensive experience in post-approval monitoring, ensuring compliance with regulatory requirements and study protocols. My role involved conducting site visits, reviewing documentation, and identifying any deviations or non-compliance issues. I worked closely with study teams to implement corrective actions and provided training to site staff to prevent future issues. My proactive approach helped maintain data integrity and ensured patient safety throughout the trial lifecycle.

I ensure adherence by conducting regular audits, reviewing site documentation, and maintaining open communication with site staff. I stay updated on regulatory guidelines and provide ongoing training to ensure compliance. By identifying potential risks early and addressing them promptly, I help sites maintain high standards and avoid regulatory issues.

I prioritize tasks based on urgency and complexity, using project management tools to track progress and deadlines. Regular communication with stakeholders ensures alignment, and I delegate tasks when necessary. By maintaining organized workflows and staying adaptable, I effectively manage multiple projects without compromising quality.

I address non-compliance by documenting the issue, communicating it to the relevant stakeholders, and developing a corrective action plan. I work collaboratively with site staff to implement solutions and provide additional training if needed. My goal is to resolve issues promptly while ensuring they do not recur.

Technology is crucial for streamlining monitoring activities. I use electronic data capture systems, audit management software, and remote monitoring tools to enhance efficiency and accuracy. These tools enable real-time data review, reduce site visit frequency, and ensure compliance with regulatory standards, ultimately improving the overall monitoring process.