Clinical Trial Coordinator / Clinical Study Administrator

About the role

The Clinical Study Administrator (CSA) supports the coordination and administration of clinical studies from start-up through execution and close-out, within the Local Study Team. The role ensures that interventional study deliverables meet time, cost and quality objectives. The schedule is standard (Monday to Friday) and the work is done in an office environment.

Key responsibilities

• Coordinate and administer clinical studies from start-up to close-out, collecting, reviewing and tracking documents for the application process.
• Assist in submitting applications and documents to the EC/IRB and, where appropriate, to regulatory authorities.
• Serve as the local administrative main contact, working closely with CRAs and the LSAD.
• Maintain the local eTMF and ISF in line with ICH-GCP and local requirements, keeping it inspection-ready and supporting close-out.
• Create and import clinical-regulatory documents into the global electronic management system, using Submission Ready Standards (SRS).
• Maintain company tracking and communication tools (e.g. CTMS, SharePoint) and prepare site-level contracts where no separate role exists.
• Handle HCO/HCP payments in line with local regulations and coordinate study materials and equipment.
• Support administrative tasks during audits and regulatory inspections, and help prepare meetings and presentation material.
• Handle local translation, printing, archiving of study-related emails and liaison with the Data Management Centre.
• Ensure compliance with the Code of Ethics, company policies and local, national and regional legislation.

Required profile

• High or secondary school diploma or equivalent; a bachelor's degree is preferred.
• Comparable experience of about 2 years, or an equivalent combination of education, training and experience.
• Good English and grammar, and proficiency in the local language as needed.
• Ability to complete the company's clinical training program.

Required skills

• Proficiency in MS Office (Word, Excel, PowerPoint).
• Ability to learn and use clinical trial database systems.
• Knowledge of country regulations, ICH-GCP and client SOPs/WPDs.
• Strong organisational skills, attention to detail and good communication skills.