Responsibilities:
1. Conduct monitoring visits at assigned clinical trial sites in accordance with GCP and the company’s SOPs, ensuring that trial data are authentic, accurate, complete, and compliant with regulatory requirements.
2. Assist with trial site initiation, execution, and close-out, including investigator selection, site initiation meetings, and trial progress monitoring.
3. Perform regular on-site and remote monitoring to ensure trials proceed as planned, promptly identifying and resolving issues.
4. Prepare and submit monitoring reports, document findings, and follow up on corrective actions.
5. Maintain strong relationships with trial sites, supporting investigators and site teams to achieve study objectives.
6. Ensure patient rights and safety are protected during trials, in line with ethical principles.
7. Support communication with ethics committees, including document submission and follow-up.
8. Collaborate with the quality management team during inspections and audits to ensure project compliance.
Requirements:
1. Bachelor’s degree or above in medicine, pharmacy, life sciences, or related fields.
2. At least 1 year of monitoring experience; prior Phase III trial or oncology experience preferred.
3. Familiar with regulations and guidelines for drug clinical trials, with solid knowledge of ICH-GCP.
4. Excellent communication, coordination, and teamwork skills; able to handle multiple tasks efficiently.
5. Strong learning ability, sense of responsibility, and resilience under pressure.
6. Willingness to travel as required.