Clinical Trials Assistant

We are looking for an organised, detail-focused and proactive Clinical Trials Coordinator to join our clinical trials team.

This is an exciting opportunity for someone with clinical trials or clinical administration experience who is looking to play a key role in the successful set-up, coordination and ongoing administration of clinical research studies.

You will act as a key point of contact for participating sites, supporting them through the set-up and recruitment process and ensuring that all required documentation, approvals, training and contracts are in place. You will work closely with internal teams, sponsors, NHS organisations, regulatory bodies and other external partners to ensure trials are delivered efficiently and in accordance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs).

Key Responsibilities

As Clinical Trials Coordinator, you will:

• Act as the first point of contact for participating clinical trial sites and support them throughout the site set-up process.
• Compile and maintain electronic Investigator Site Files (e-ISFs), assisting sites to complete all required documentation.
• Liaise with sponsor contracts teams to ensure contracts are in place before site recruitment begins.
• Ensure Material Transfer Agreements (MTAs) are in place and track biological samples and shipments for the EMPIRE collaboration.
• Review site documentation and provide greenlight approval for sites to begin recruitment once all required requirements have been met.
• Provide training documentation, review training records and arrange access to relevant trial systems.
• Assist with clinical trial applications and amendments to regulatory and governance bodies, including the MHRA, Research Ethics Committees, HRA and NHS R&D.
• Monitor approvals and ensure all necessary trial and site approvals are obtained within required timelines.
• Create, review and update trial documentation, ensuring information is accurate, clear and appropriately maintained.
• Build effective working relationships with a wide range of internal and external stakeholders.
• Arrange and contribute to operational and steering meetings and teleconferences, including preparing agendas, reports and minutes and distributing documentation promptly.
• Review monthly screening logs received from recruiting sites.
• Manage the trial inbox and ensure queries and correspondence are dealt with promptly.
• Create and maintain trial master files, site files and other trial-related filing systems.
• Provide administrative support across the clinical trials team and assist with the wider activities of the team as required.
• Undertake general administrative duties, including document management, filing, stationery orders, copying, mailing and arranging couriers.
• Deal professionally with telephone enquiries and provide appropriate support to colleagues.
• Provide cover for colleagues during periods of annual leave.
• Take responsibility for your own personal and professional development.
• Work in accordance with Trust, University and Unit policies, procedures and guidelines, as well as legal and statutory requirements.
• Undertake any other duties appropriate to the grade of the post as requested by the Unit Director or Director of Operations.

Essential Criteria

We are seeking an individual who is highly organised, dependable and able to manage multiple priorities while maintaining a high level of accuracy.

You will have:

• Experience of working within clinical trials or clinical administration.
• Knowledge and understanding of the clinical trial approval process and site set-up, including ethics and HRA requirements.
• A strong understanding of confidentiality, governance and the importance of maintaining accurate trial documentation