In my previous role, I was responsible for ensuring all trial protocols adhered to FDA and international guidelines. I conducted regular audits of trial sites to verify compliance with Good Clinical Practice (GCP) and managed documentation for regulatory submissions. This involved coordinating with various stakeholders to address any compliance issues promptly, ensuring the integrity and validity of trial data.

I prioritize tasks based on deadlines and criticality, using project management tools like Gantt charts and task lists. I maintain open communication with all team members and stakeholders to ensure everyone is aligned on timelines and objectives. Regular meetings and updates help manage expectations and address any issues that arise, ensuring smooth progress across all trials.

I ensure that all trial protocols include comprehensive safety measures and that informed consent is properly obtained. I monitor adverse events closely, reporting them promptly to the ethics committee and regulatory bodies. Additionally, I provide regular training to site staff on patient safety protocols to reinforce best practices and ensure a vigilant approach to patient well-being.

I build strong, collaborative relationships by maintaining regular communication and transparency. I understand the needs and expectations of both sites and sponsors, and I work to align these with the trial objectives. By providing timely updates and addressing concerns proactively, I ensure mutual trust and cooperation, which is crucial for the successful execution of clinical trials.

In a previous trial, we faced a significant delay due to a protocol amendment. I quickly organized a meeting with the regulatory team and trial sites to discuss the changes and their implementation. I developed a revised timeline and ensured all parties were trained on the new procedures. This proactive approach minimized the impact on the trial timeline and maintained participant enrollment.