Ref #: 34053

Employment type: Permanent - Full-Time

Location: Prague

Posted: 03-Dec-2021


Purpose of Role
The Clinical Trial Assistant will assist clinical trial operations, with in-house activities associated with the management of assigned clinical projects and will have the responsibility for all administrative activities including communication, file management, tracking databases and supply inventory activities. The trials assigned may be either sponsored by the company or conducted on behalf of its partners. The position will work within the Head of Clinical Operations group and will report into an assigned Senior Clinical Project Manager

Key Accountabilities;
• Provide administrative support for projects
• Create, update, track, and maintain project-specific trial management files, tools, and systems.
• Ensure project and study files (Trial Master File (TMF)) are set up maintained and audit ready at all times, both on paper and electronically. This involves filing of documents and regular QC checks.
• Assist publishing and administrative QC of all project-specific documents (e.g. protocols, investigator brochure, and regulatory submissions) in a timely manner.
• Track regulatory and ethics submissions, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools.
• Assist with the management and tracking of study non-clinical supplies to sites and organize shipments.
• Assist with management and tracking of study clinical supply.
• Co-ordinate meetings with clients, investigators and internal teams. This includes scheduling, sending invitations, preparation of agenda, materials and presentations and taking accurate and complete minutes.
• Act as a contact for project team and study sites.
• Take responsibility for various project administrative activities, as required.
• Create, update and maintain clinical department management tools and systems, as required.

What is required
• Administrative experience in a corporate environment or preferably, Clinical Project Administrator experience.
• Minimum of A levels or equivalent. Degree level preferred
• Basic knowledge of ICH-GCP and relevant regulations.
• Excellent oral and written communication skills.
• Highly methodical and organized, including time-management skills and changing priorities
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail
• Ability to set priorities and handle multiple tasks simultaneously.
• Able to take initiative and work independently; sense of urgency in completing assigned tasks
• Accurate with a strong focus on attention to detail.

What is offered
• Full-time
• Permanent career opportunity
• Office based in Prague, Czech Republic
• Market leading salary range will depend on level of skills and experience
• Competitive salary plus company benefits