Clinical Research Associate
Current- Conducted interim and closeout hospital/clinic visits at investigative sites, administering protocol training and other essential guidance, while maintaining open communication to address ongoing site issues and manage expectations.- Developed and implemented a query management system, achieving a 99.3% completion rate for study data, significantly improving data quality and accuracy.- Translated internal clinical study documents from Spanish to English, ensuring clarity and accuracy in study operations across language barriers.- Led bi-monthly internal Clinical Team meetings, fostering collaboration and driving progress on key clinical trial objectives.- Performed rigorous internal database quality checks, ensuring data integrity and completeness throughout the study lifecycleEnsured timely and accurate data entry into the clinical database, promptly addressing and resolving any identified issues to maintain study timelines.- Generated comprehensive and timely reports and follow-up letters aftereach site visit, escalating any quality concerns to upper management when necessary.- Evaluated site quality and adherence to protocols, ensuring compliancewith regulatory standards and maintaining the integrity of the study.- Managed and tracked essential documents within the Trial Master File (TMF) and Investigator Site File (ISF), ensuring adherence to Good Clinical Practice (GCP) and local regulatory requirements.- Coordinated submissions and correspondence with IRBs/Ethics Committees, ensuring smooth regulatory approval processes.- Collaborated closely with cross-functional study teams, prioritizing tasks and ensuring that all project milestones and objectives were successfully met.- Established strong, trust-based relationships with physicians, research staff, project teams, and study sponsors through clear communication and a commitment to exceeding expectations.