We are delighted to be recruiting a Clinical Trial Assistant  to join our client in Central London and to start work ASAP. You will need to have right to work in the UK and be able to get to their great new offices in London. The CTA is a key member of the project team and will provide in-house operational support to study teams, ensuring standardisation and consistency of tracking across studies in accordance with SOPs. 

Role Summary  

The Clinical Trial Assistant (CTA) is a key member of the Clinical Operations team, providing operational and administrative support across multiple clinical studies. The CTA is responsible for ensuring study documentation, systems and trial records are maintained to the highest quality standards, supporting inspection readiness and efficient study delivery in accordance with ICH-GCP, SOPs and applicable regulations.  

Key Responsibilities  

• Provide day-to-day operational support to Clinical Project Managers (CPMs), Clinical Research Associates (CRAs) and study teams across multiple studies.  

• Coordinate, maintain and quality check Trial Master File (TMF) documentation to ensure completeness, accuracy and inspection readiness.  

• Conduct routine TMF reviews, reconciliation activities and follow-up of missing or outstanding essential documents.  

• Support study start-up activities including collection, review and tracking of regulatory and site activation documentation.  

• Maintain study information within eTMF, CTMS and other clinical systems, ensuring data accuracy and timely updates.  

• Support Health Authority, Ethics Committee and IRB submissions and maintain oversight of approvals, amendments and renewals.  

• Develop, maintain and monitor study trackers, action logs, risk logs and operational reports.  

• Produce study metrics, dashboards and status updates for study teams and senior management.  

• Coordinate investigator meetings, study team meetings and training events, including logistics, agendas, presentation materials and meeting minutes.  

• Support vendor management activities by maintaining documentation, tracking deliverables and following up on actions.  

• Develop and distribute newsletters, study communications and updates to investigators, monitors and stakeholders.  

• Maintain study collaboration sites, document repositories and access permissions.  

• Support preparation of clinical study reports, publications and regulatory documentation packages.  

• Assist with audit and inspection readiness activities, including document retrieval, reconciliation and issue resolution.  

• Identify, track and escalate operational issues, study risks and documentation gaps appropriately.  

• Coordinate study training activities and maintain associated training records.  

• Document lessons learned, share best practices and contribute to continuous process improvement initiatives.  

• Mentor and provide guidance to junior study support staff where appropriate.  

• Ensure compliance with ICH-GCP, applicable regulations, SOPs and company policies at all times.  

• Undertake additional responsibilities as directed within the scope of the role.  

Essential Experience & Qualifications  

• Minimum 5 years of experience as a Clinical Trial Assistant, Senior CTA, Clinical Trial Coordinator or similar clinical operations role.  

• Experience supporting multicentre and/or global clinical trials within a CRO, pharmaceutical or biotechnology environment.  

• Working knowledge of ICH-GCP, clinical trial regulations and essential document requirements.  

• Experience working with eTMF systems, CTMS and Microsoft Office applications.  

Skills &