Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
Protect patients. Review the performance of the trial at designated sites, ensure the rights and well-being of human subjects are safeguarded and are in accordance with protocol.
Drive productivity. Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, while also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.
Execute. Monitor the completeness and quality of Regulatory Documentation and perform site document verification