Clinical Trial Assistant

Company Overview
Global provider of outsourced drug development services to biopharma, medical device, government, biosimilar and generic organisations.

Job Description
• To provide general administrative support to the Clinical Research Services team.
• To be familiar with ICH GCP, appropriate regulations, relevant internal tracking systems.
• To be familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.
• To assist project teams with study specific documentation and guidelines as appropriate.
• 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.
• To process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.
• To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
• To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
• To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
• To copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
• To assist in co-ordination of Investigator payments, if applicable.
• To contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
• To assist in the tracking and distribution of safety reports.
• To attend project team meetings and generate meeting minutes.
• To assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
• To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
• To assist with the coordination of team member tracking.
• Other duties as assigned

Requirements
・Native level Japanese and Business level English
・+３ years of any administrative experience

Additional Job Information
They care about our people as they are the key to our success. They provide an open and friendly work environment where they empower people and provide them with opportunities to develop their long term career.

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