Company OverviewGlobal 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