职位描述
- 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 (ISF, CRF, etc),
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.
以担保或任何理由索取财物，扣押证照，均涉嫌违法，请提高警惕