临床监查员 CRA I/II（FSP）

- Perform site monitoring and other onsite visit activities according to monitoring plan and in compliance with procedural documents.

- Provide the required monitoring visit reports within required timelines.

- Proactively identify study-related issues and escalates to Local Study Teams as appropriate.

- Contribute to the selection of potential sites and investigators.

- Train, support and advise Investigators and site staff in study related matters.

Obtain and maintain essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations.

- Manage study supplies, drug supplies and drug accountability at study sites.

- Perform source data verification according to SDV plan. Ensure data query resolution.

- Work with data management to ensure quality of the study data.

- Ensure accurate and timely reporting of Serious Adverse Events.

- Share relevant information on patient recruitment and study site progress within local Study Team.

- Update VCV and other systems with data from centres as per required timelines.

- Prepare for activities associated with audits and regulatory inspections in liaison with local Study Team Lead and QA.