Clinical Trial Coordinator – FSP Bench

About the role

The Clinical Trial Coordinator (also known as Clinical Study Administrator) supports the end‑to‑end execution of interventional studies, ensuring that study documentation, regulatory submissions and site activities are managed on time and in compliance with ICH‑GCP and local regulations. Working within the Local Study Team, you will act as the primary administrative contact for investigators, CROs and internal stakeholders.

Key responsibilities

• Coordinate study start‑up, execution and close‑out activities, including preparation and tracking of application documents for EC/IRB and regulatory authorities.
• Maintain the local electronic Trial Master File (eTMF) and Investigator Site File (ISF), ensuring timely document upload, inspection readiness and final archiving.
• Create, import and manage clinical‑regulatory documents in the global electronic management system, adhering to company authoring guides and Submission Ready Standards.
• Set up and update study information in systems such as CTMS and SharePoint, and support users of these tools.
• Assist with site contract preparation, HCO/HCP payments, and coordination of study materials and equipment.
• Organise internal and external meetings, prepare presentation material, and handle document printing, distribution and archiving.

Required profile

• High school diploma or equivalent; a bachelor’s degree is preferred.
• At least two years of relevant experience in clinical trial administration or a comparable combination of education and experience.
• Strong knowledge of local regulations, ICH‑GCP and standard operating procedures.
• Fluent English with good written and spoken skills; proficiency in the local language as required.

Required skills

• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Experience with Clinical Trial Management Systems (CTMS) and SharePoint.
• Hands‑on experience with electronic Trial Master File (eTMF) and document tracking systems.
• Ability to work with regulatory submission standards (SRS) and electronic filing tools.