临床监查员（CRA),上海北京广州

Key Responsibilities Operational Conduct of Clinical Studies/临床试验运营执行 一. Pre-study Activities 1. Assist Study Manager and sponsor representatives to sites and investigators identification and selection, including site feasibilities. 2. Assist Study Manager and sponsor representatives with preparation of study budget. 3. Prepare documentation for Ethics Committee submission and HGRAC application. 4. Coordinate receipt and distribution of clinical trial supplies. 5. Ensure required documents ready for site initiation process. 6. Liaise with investigators and site staff regularly to ensure effective initiation of studies. 7. Develop appropriate monitoring tools. 8. Support Sponsor& Study Manager to organize investigator meetings within budget. 二. Site Monitoring Activities 1. Prepare and conduct initiation visits according to Study Monitoring Plan. 2. Oversee assigned clinical trials to ensure compliance with ICH-GCP guidance, local regulation, and the SOPs of Sponsor and /or dMed. 3. Monitor and document the progress of assigned clinical studies through regular visits and telephone contact with site personnel following with Study Monitoring Plan. 3. Liaise with Study Manager regularly on study status through monitoring reports and meetings. 4. Liaise with other CRAs on study progress to maintain consistency if working on the same study.。 5. Document all study related communications in a timely manner. 6. Perform Source Data Verification to ensure accurate data is recorded in a timely manner. 7. Ensure all Serious Adverse Events are reported timely and followed up according to regulatory requirements, Sponsor and/or dMed SOPs. 8. Maintain drug accountability of all clinical supplies and arrange for destruction as per specified clinical study. 9. Ensure study documentation for each clinical trial is complete and returned to Sponsor or dMed in accordance with set schedules. 10. Ensure documentation is maintained according to Sponsor or dMed SOPs. 11. Track site payments to ensure payments are on time and within budget. 12. Coordinate the resolution of data queries within a required timeframe. 13. Perform or support site self-assessment if required by site/sponsor. 14. Perform study closeout visits at the completion of database lock. 15. Support & coordinate with site to achieve site master files to ensure the competence and also to meet the requirements of site GCP office. 16. Support site audit or inspection if any and ensure the CAPA completion with the required timeframe. Reporting 1. Accurate completion of Monitoring visit reports with the required timeframe and ensure all issues are correctly identified and categorized. 2. Ensure regular updating of trial management systems. 3. Prepare study progress reports for Study Manager /Sponsor by specified dates, which is copied to manager of site management. 4. Ensure all significant quality issues identified in the site are reported per Sponsor/dMed SOP requirement.