北京市,广东省-广州市,四川省-成都市 | 若干人
• 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 Team 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.
• Additional tasks assigned by manager, include but not limited: study level tasks associated with Country Study Manager (CSM), act as a mentor for junior team member, co-monitor less experience CRA within study team.
• Contribute to process improvements, knowledge transfer and best practice sharing.
• Bachelor degree in biological science or healthcare-related field, or equivalent
• Minimum 3-year experience as CRA or other related fields.
• Have proven track record on performance of site management and monitoring delivery.
• Solid understanding of the clinical dataflow
• Excellent knowledge of the clinical study and drug development processes, GCP/ICH guidelines and relevant local regulations
• Good computer skills in Microsoft and other software.
• Fluent in both oral and written English.