In my previous role, I was responsible for ensuring that all clinical trial activities adhered to established protocols and regulatory standards, such as GCP and FDA guidelines. I conducted regular audits, maintained detailed documentation, and collaborated with cross-functional teams to address compliance issues. My experience has equipped me with a strong understanding of the importance of accuracy and adherence to regulatory requirements in clinical investigations.

I utilize electronic data capture (EDC) systems and other tools to ensure accurate and efficient data collection. I follow strict protocols to maintain data integrity, including double-checking entries and resolving discrepancies promptly. My approach emphasizes organization, attention to detail, and adherence to confidentiality standards to ensure reliable and secure data management throughout the investigation process.

Participant safety is my top priority. I closely monitor adverse events, ensure informed consent is obtained, and verify that all procedures align with ethical and safety standards. I maintain open communication with participants and the research team to address concerns promptly. By adhering to safety protocols and staying vigilant, I contribute to a secure and ethical clinical trial environment.

I use project management tools to organize tasks, set deadlines, and track progress. I prioritize based on urgency, regulatory requirements, and trial milestones. Regular communication with team members helps me stay aligned with project goals. My ability to multitask and adapt ensures that all investigations progress efficiently without compromising quality or compliance.

During a trial, we encountered a discrepancy in data collection forms. I immediately initiated a root cause analysis, identified the issue as a miscommunication in protocol interpretation, and retrained the team to prevent recurrence. By addressing the problem swiftly and implementing corrective measures, I ensured the trial's integrity and maintained compliance with regulatory standards.