In my previous role, I was responsible for maintaining and organizing clinical trial documentation, ensuring compliance with regulatory standards. I handled protocols, informed consent forms, and case report forms, ensuring accuracy and confidentiality. I also coordinated with investigators and sponsors to update and archive documents, streamlining the process for audits and inspections.

I use a combination of project management tools and prioritization techniques to manage multiple trials. I create detailed schedules, set deadlines, and categorize tasks by urgency and importance. Regular communication with team members helps me stay updated on progress and adjust priorities as needed to ensure all trials run smoothly and deadlines are met.

I have extensive experience ensuring compliance with regulations such as GCP, HIPAA, and FDA guidelines. I regularly review and update documentation to meet regulatory standards, conduct internal audits, and prepare for external inspections. My attention to detail and knowledge of compliance requirements help maintain the integrity of clinical trials and avoid potential issues.

I strictly adhere to confidentiality protocols, ensuring patient information is securely stored and accessed only by authorized personnel. I use encrypted systems for data storage and follow HIPAA guidelines to protect sensitive information. Regular training on data privacy and security keeps me updated on best practices to maintain patient confidentiality.

I am proficient in using tools like Microsoft Excel, SharePoint, and clinical trial management systems (CTMS) such as Medidata and Oracle Clinical. These tools help me efficiently manage data, track trial progress, and generate reports. My technical skills ensure accurate data entry, analysis, and reporting, supporting the overall success of clinical trials.