Quality Assurance Quality Control

This position ensures that clinical trials comply with the latest regulatory requirements and guidelines, and to make sure that systems are in place, and effectively operated, which ensure that clinical trials data is credible and that the rights, integrity, and confidentiality of subjects are protected. Perform system audits of quality system elements at the sponsor and any contractor taking over responsibilities in a clinical study to ensure its effectiveness and efficiency. Perform study audits at sponsors as well as at investigators sites to ensure compliance with regulatory requirements, Good Clinical Practice principles and study protocols. Organize the preparation and updating of the standard operating procedures in close cooperation with the staff of clinical research and corporate QA.