至少有1年的CRA相关经验

- Drive study performance at the sites.
- 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.