Key tasks including

• Coordinates the collection and entry of project tracking including but not limited to the following essential documents, patient data, site visit dates, protocol deviations, and trip reports into tracking systems.
• Provides logistic and administrative support to project teams(personal travel, compensation, event organization)
• Communicates project status to the project team as appropriate.
• Scans and copies project documentation inclusive of, but not limited to, essential documents, CRFs, and DCFs.
• Copies, collates and produces study binders.
• Reviews deliverable to ensure accuracy of content and materials copied.
• Supports the project team in preparation of documentation for Regulatory and Ethical Submissions.
• Organizes study documents and materials in compliance with Project SOPs regarding regulatory documentation as appropriate.
• Archives project related documentation.
• Reports all document collection and tracking issues to project team on a regular basis
• Establishes and maintains QC of the Trial Master File in accordance with project, organizational and regulatory requirements.
  

Requirement:

• College graduate, preferably with a healthcare or life science degree
• Preferably Good knowledge of ICH-GCP, GCP and local clinical trial regulations
• Basic computer skill (MS Office, Internet, etc)
• Ability to work independently and as part of a team
• Self-initiative to perform duties, with good analytical and problem-solving capabilities Ability to handle multiple tasks and expected to follow through with completion of assigned tasks with minimal supervision
• Preferably > 1 year experience of clinical trial assistant
• English: Good at speaking, writing

上班地址：上海张江哈雷路866号