Job Description

1. 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.

2. Provides logistic and administrative support to project teams.

3. Communicates project status to the project team as appropriate.

4. Scans and copies project documentation inclusive of, but not limited to, essential documents, CRFs, and DCFs.

5. Copies, collates and produces study binders.

6. Reviews deliverable to ensure accuracy of content and materials copied.

7. Supports the project team in preparation of documentation for Regulatory and Ethical Submissions.

8. Organizes study documents and materials in compliance with Project SOPs regarding regulatory documentation as appropriate.

9. Archives project related documentation.

10. Reports all document collection and tracking issues to project team on a regular basis

11. Establishes and maintains QC of the Trial Master File in accordance with project, organizational and regulatory requirements.

Requirement:

1. College and above graduate, preferably with a healthcare or life science degree

2. Good knowledge of ICH-GCP, GCP and local clinical trial regulations

3. Basic computer skill (MS Office, Internet, etc)

4. Ability to work independently and as part of a team

5. 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

6. More than 1 year experience of clinical trial assistant is a plus

7. English: Good at speaking, writing

上班地址：枫林路420号