ul>Manage all aspects of a study ensuring adherence to the protocol, GCP, and applicable regulations, including participating in the informed consent process, coordinating, and performing all study visit procedures per protocol, managing Investigational Product and study related supplies and equipment, assisting with monitoring visits, attending Investigator Meetings, and assisting with query resolution, as required. Facilitate ongoing Quality Assurance (QA) review of studies, in collaboration with the QA department, including assisting with risk assessments, root cause analysis, and development of corrective and preventative actions as applicable.