Project Officer (Health) – Clinical Trial Ethics

About the role

We are seeking a Project Officer to support the management of clinical trial ethics reviews on an 11‑month contract. The role involves guiding applicants, coordinating ethics committee activities, and ensuring compliance with the Clinical Trials Regulation.

Key responsibilities

• Provide guidance and respond to queries from prospective trial sponsors and applicants.
• Manage ethics review applications from submission through decision and post‑approval monitoring.
• Organise ethics committee meetings, prepare agendas, distribute materials and record minutes.
• Coordinate preparation and review of ethics application dossiers and substantial modification requests.
• Maintain proficiency in the Clinical Trial Information System (CTIS) and track applications against legislative timelines.
• Develop and refine SOPs, internal processes, and policy documents related to ethics review.
• Support fee monitoring, financial administration and stakeholder communications.
• Conduct literature and legislative research to inform policy and best‑practice guidance.

Required profile

• Strong knowledge of the Clinical Trials Regulation (CTR) and related European health research legislation.
• Experience working with ethics committees and handling clinical trial documentation.
• Excellent organisational skills and ability to manage multiple deadlines.
• Proactive attitude towards continuous improvement and policy development.

Required skills

• Proficiency with the Clinical Trial Information System (CTIS).