Location: Shanghai
Job Type: Onsite, Full-time employee
Reporting to: Clinical Project Manager

Responsibilities:
- Acts as the main line of communication between the sponsor and the investigators.
- Initiates, monitors and closes study sites in compliance with Procedural Documents, protocols, ICH/GCP Guidelines and other local regulations as applicable.
- Obtains and maintains essential documentation in compliance with ICH-GCP, Procedural Documents and local regulations both in the office and at site.
- Drives performance at the sites. Proactively identifies study-related issues and escalates as appropriate.
- Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented.
- Trains, supports and advises Investigators and site staff in study related matters.
- Motivates/influences the site to meet study objectives, including enrolment and retention goals. Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method.
- Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner.
- Manages study supplies (ISF, CRF, etc), IP and trial materials and drug accountability at study sites.
- Actively participates in Study Team meetings and Investigator meetings.
- Prepares for activities associated with audits and regulatory inspections in liaison with study team and QA.
- Ensures completeness and quality of data submitted from study sites.
- Other tasks and responsibilities as needed.

Qualification:
- Bachelor degree in medicine, science or related disciplines.
- Strong communication skill
- At least 2 years clinical operation monitor experience for senior CRA position.
- Knowledge of Good Clinical Practice (GCPs), ICH Guidelines, and local regulations, research processes and scientific knowledge as related to clinical trial conduct.
- Adequate verbal and written English skills.
- Ability to travel nationally as required.
- Understanding of clinical landscape with practical knowledge in a variety of medical settings and medical records management.

其他信息


所属部门：临床医学部