Clinical Trial Administrator

Requirements

Experience
- Essential

We are seeking a Clinical Trial Administrator to provide high-quality comprehensive administrative and operational support to the Clinical Operations team, working closely with the Clinical Trial Coordinators and wider Clinical Operation team.

The role supports Head of Clinical Operations, Head Office staff and those working within the EMS Community Research Units ensuring study documentation, systems and processes are maintained to a high standard of organisation, accuracy and regulatory compliance.

The post holder plays a key role in supporting efficient study start-up, ongoing trial conduct, and quality oversight across the multiple research locations, in accordance with Good Clinical Practice (GCP) and EMS Healthcare SOPs.

• Maintain study filing systems (electronic and paper), ensuring documents are correctly named, version controlled, stored, and archived.
• Prepare routine study documentation, including templates, labels, forms, participant packs, and training materials.
• Upload, scan, index and quality-check documents within trial platforms and shared systems (e.g. Investigator Site Files. Clinical Trial Management Systems, SharePoint etc.).
• Maintain trackers, logs (e.g., training logs, delegation logs, document receipt logs, sample trackers, site trackers).
• Support document reconciliation and completeness checks in-line with SOP requirements.
• Assist with the preparation and maintenance of controlled templates and master documents.

• Work closely with Clinical Trial Coordinators and the wider Clinical Operations Team to support study set-up, coordination and ongoing trial activities
• Provide administrative assistance for study milestones, site readiness activities, and monitoring preparation.
• Support preparation of operational reports, meeting materials, and study status updates.
• Assist with cross-functional coordination between Clinical Operations, Projects. Quality, and Operational teams.
• Provide diary management and meeting coordination for the Clinical Operations team as required.
• Support action tracking and follow-up from relevant Clinical Operational related meetings.

• Provide remote administrative support to community-based research sites.
• Act as a central administrative contact for non-clinical site queries.
• Support site onboarding processes, including documentation collection, training records, and system access coordination.
• Maintain oversight of site essential documentation (e.g., CVs, GCP certificates, delegation logs).
• Assist sites in preparing documentation for monitoring visits, audits, and internal quality checks.
• Escalate documentation gaps or compliance risks to the Clinical Operations team.

• Assist in preparing study materials and supplies for site initiation and ongoing study visits.
• Coordinate shipment of documentation and study materials where required.
• Prepare meeting rooms and materials for internal briefings, audits, and study meetings.
• Support organisation of internal training sessions, including attendance tracking and document collation.

• Support accurate data entry into administrative dashboards and study trackers.
• Generate simple system exports, reports, and lists for Clinical Operations Team as well as project meetings, EMS internal governance meetings and others as required.
• Assist with user access documentation and onboarding paperwork for study staff.
• Support periodic system reconciliation activities (e.g., ISF completeness checks).
• Maintain accurate operational metrics for Clinical Operations oversight.

• Ensure all administrative activities are conducted in accordance with ICH-GCP, GDPR, and EMS Healthcare SOPs.
• Maintain strict confidentiality of participant and study data.
• Conduct basic internal file quality checks and flag discrepancies.
• Support collection of documentation for deviations, incidents, CAPAs, and audit responses.
• Contribute to a culture of continuous improvement within Clinical Operations.

Experience
- Essential

• Strong administrative experience in a structured, process-driven environment.
• Demonstrable experience managing documentation with high attention to detail.
• Excellent organisational skills with the ability to manage multiple priorities.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office (Word, Excel, Outlook) and document management platforms.
• Ability to work collaboratively within a team and support geographically dispersed stakeholders.
• Ability to recognise problems, think logically through solution, and seek guidance when required.

• Experience with in a healthcare, clinical research, regulatory, or quality-controlled environment.
• Awareness of ICH-GCP principles or willingness to undertake GCP training.
• Experience supporting remote teams or multi-site operations.
• Exposure to…