Job Description

1. To provide general administrative support to the Clinical Operations Department and assistance to Project Manager(s) and Project Director(s).
2. To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
3. To support the Clinical Operations teams with ongoing conduct of studies.
4. To assist project teams with study specific documentation and guidelines as appropriate.
5. To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
6. To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
7. To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
8. To assist in co-ordination of Investigator payments, if applicable.
9. To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
10. To attend project team meetings and generate meeting minutes.
11. To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
12. To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
13. Other duties as assigned.

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