南京招聘

Essential Job Function

? Lead the effective operation of clinical research activities as designated by the Director of Clinical Research Office in collaboration with principal investigators or study sponsors; identify problems or obstacles in the system/procedures related to implementation of research protocols and communicate to the study investigator(s); provide overall coordination and facilitation of clinical research activities to ensure patient safety and data integrity.

根据上级的指派，负责与主要研究者或申办方合作，推进临床研究工作的高效运行；发现研究方案实施过程中存在的问题和困难，并及时与研究者沟通；负责临床研究活动的全面协调和推进，确保患者安全和数据质量。

? Assist in the development of study budget and negotiation of study agreement; coordinate the protocol administration including initial protocol submission, subsequent protocol revisions, closure and termination; communicate closely with the IRB office and ensure timely regulatory reporting and distribution of IRB directives.

协助完成研究预算和研究合同；协调方案管理工作：方案提交、方案修正、结题和终止；与伦理委员会办公室密切合作，确保及时完成事件汇报，并及时分配伦理委员会布置的工作。

? Supervise the study conduct and evaluate staff workload and assignment to ensure the compliance with protocol requirements, regulations, GCP, institutional policies and quality measures.

监管研究工作的实施，评估工作人员的工作量和任务分配，确保各项操作均符合方案要求、法律法规、GCP、医院制度和质量标准。

? Set performance expectations for all subordinates and is responsible for hiring, development, coaching, evaluating and disciplining of all assigned staff.

设置下属的绩效指标，负责招聘、发展、指导、评估、训练下属人员。

? Utilize quality improvement tools and statistical process control to facilitate improvement of clinical research systems and processes.

运用质量提升工具和统计过程控制，优化临床研究体系和流程。

? Coordinate, plan and develop training programs for professional and ancillary staff on research protocols, policies and procedures.

协调、规划、开发针对专业人员和辅助人员的培训项目，包括研究方案、制度和流程。

? Other duties as assigned by the Director of Clinical Research Office.

上级交派的其他任务。

Supervision

Received: Director of Clinical Research Office or designee

Given: Assigned staff

Education

Bachelor of Medicine, Bachelor of Surgery (MBBS) or Bachelor degree in other healthcare related professions

本科及以上学历，临床医学或其他医药相关专业

Experience

? Minimum of 5 years in clinical practice including minimum of 2 years in supervision or a research administration role

至少5年临床工作经验，包括至少2年管理岗位的工作经验

? Experience in initiating and development of new research unit/service is preferred

拥有临床研究中心筹建经验者优先

? May substitute required years of supervisory experience with additional years of equivalent experience on a one to one basis.

根据个人情况，管理工作经验可由其他类似的岗位经验代替。

Licensure and Certification

? Active medical license, nursing license, or other healthcare related professional license to practice in China is preferred

持有有效的执业医师证书，护士执业证书或其他医药相关的执业证书者优先

? GCP Certification/证书

Other Requirements

? Excellent written and oral communication skills

优秀的书面和口头沟通技能

? Fluent in Mandarin Chinese and English

流利的普通话和英语

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