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.Communicates project status to the project team as appropriate.

3.Assists in the retrieval and resolution of issues with transmittals.

4.Scans and copies project documentation inclusive of, but not limited to, essential documents, CSAs, 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 and/or Sponsor SOPs regarding regulatory documentation as appropriate.

9.Archives study documentation and returns TMF to sponsor, as directed.

10.Reports all document collection and tracking issues to SMS Team Lead and/or project team on a regular basis

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

Requirement:

College graduate, preferably with a healthcare or life science degree

Secondary school (GCSE) completion and / or high school diploma considered with prior work experience

More than 1 year experience of clinical trial assistant

English: Good at speaking, writing

上班地址：上海