1. Responsible for the performance of assigned sites in accordance with Good Clinical Practice (GCP), ICH guidelines
and federal regulations.
2. Coordinates and administers research study associated activities.
3. Assists in project planning, and ensures that pre-established work scope, study protocol, regulatory requirements are followed.
4. Recruits and coordinates research subjects, as appropriate to specific study objectives and work scopes.
5. Serves as principle administrative liaison for the project.
6. Supervises and coordinates the provision of support services to investigators and researchers.
7. Develops and maintains record-keeping systems and procedures.
8. To implement quality control process throughout the conduct of the trial.
1.根据良好临床实践(GCP)、ICH指南,负责指定地点的绩效
以及联邦法规。
2.协调和管理与研究相关的活动。
3.协助项目规划,并确保预先确定的工作范围、研究方案、法规要求的遵循。
4.根据具体的研究目标和工作范围,招募和协调研究对象。
5.担任本项目的主要行政联络人。
6.监督和协调向调查人员和研究人员提供支助服务。
7.制定和维护记录保存系统和程序。
8.在整个试验过程中实施质量控制流程。