崗位職責:
1、協助項目經理完成試驗核心文件的收集、整理、核查和歸檔;Assist the project manager in collecting, organizing, checking, and archiving the core documents of the trial.
2、協助項目經理收集試驗相關信息,負責對臨床試驗進度做整體跟進、匯總及匯報;Assist the project manager in collecting relevant information for the trial, and be responsible for the overall follow-up, summarization, and reporting of the clinical trial progress.
3、跟進項目監查計劃、重點問題處理的執行情況;Follow up on the implementation of the project monitoring plan and the handling of key issues.
4、協助項目組召集、組織網絡及電話會議,組織、籌備、協調項目現場會議;Assist the project team in convening and organizing online and telephone meetings, and organize, prepare for, and coordinate on-site project meetings.
5、負責處理項目組其他行政工作;Be responsible for handling other administrative tasks of the project team.
6、完成上級經理分配的其他工作。Complete other tasks assigned by the supervisor.
任職要求:
1.本科及以上學歷,臨床醫學、預防醫學、臨床藥學等臨床相關專業優先;Bachelor
s degree or above, with priority given to clinical-related majors such as clinical medicine, preventive medicine, and clinical pharmacy
2.熟悉藥物臨床試驗管理規范(GCP)和臨床工作相關法規,了解臨床研究實施流程;Be familiar with the Good Clinical Practice (GCP) and relevant regulations for clinical work, and understand the implementation process of clinical research.
3.有良好的工作態度,工作嚴謹,有責任心,協調溝通能力強,有良好的團隊精神與合作意識;Have a good work attitude, be rigorous in work, responsible, with strong coordination and communication skills, and possess good team spirit and cooperative awareness.
4.熟練應用電腦及辦公軟件;Proficient in computer operation and office software