Clinical Research Associate (CRA)

Jobinhalt

• 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.