Detailed job description and main responsibilities

In this role, your key responsibilities will include supporting  the delivery of research studies throughout the study lifecycle, from initial setup through to study closure and archiving. Working closely with Research Nurses, Clinical Research Practitioners, Principal Investigators, and the Research & Development Department, you will help ensure studies are conducted in accordance with protocol requirements, Good Clinical Practice (GCP), and relevant regulatory standards

The University Hospital Southampton NHS Foundation Trust (UHS) Trustwide Research Team is delighted to offer an exciting opportunity for an organised, proactive, and motivated individual to join our growing research workforce as a Senior Clinical Trials Assistant.
This role is ideally suited to an individual with experience in healthcare, research administration, clinical trials support, or clinical data management who enjoys working in a fast-paced environment and is passionate about improving patient care through research. As part of the Trustwide Research Team, you will support the delivery of a diverse portfolio of clinical research studies across multiple specialties, helping to ensure studies are delivered safely, efficiently, and in accordance with regulatory requirements.
We are looking for someone with excellent organisational skills, strong attention to detail, and the ability to work both independently and as part of a multidisciplinary team. The successful candidate will be confident using a range of IT systems, managing complex study documentation, maintaining accurate research records, and communicating effectively with patients, clinical teams, sponsors, and research colleagues.
As a Senior Clinical Trials Assistant, you will play a key role in supporting study setup, participant recruitment, data collection, study administration, and trial coordination activities. You will assist research teams to ensure studies are delivered in line with study protocols, Good Clinical Practice (GCP), and Trust policies. You will also provide day-to-day support and guidance to junior administrative and research support staff, helping to maintain high standards across the research team. 
This is an excellent opportunity for someone looking to further develop a career in clinical research while contributing to studies that improve outcomes for patients locally, nationally, and internationally.
Job Responsibilities

You will coordinate and maintain study documentation, including Investigator Site Files, study trackers, screening logs, enrolment logs, delegation logs, and trial master file documentation, ensuring records remain accurate, complete, and audit-ready at all times. 
The post holder will support participant recruitment activities, including identifying potential participants through approved pathways, coordinating appointments, arranging follow-up visits, maintaining participant contact. You will contribute to ensuring participants receive a positive and professional research experience throughout their involvement in studies.
You will assist with the collection, transcription, verification, and entry of research data from source documents into paper and electronic case report forms, ensuring data is complete, accurate, and submitted within study timelines. You will also assist with resolving data queries raised by sponsors and coordinating monitoring visits and audits. 
The role will involve coordinating study logistics, including arranging study visits, ordering and tracking documentation, managing study correspondence, preparing paperwork for monitoring visits, coordinating sample shipments where required, and supporting study archiving activities. 
You will maintain and update research databases, including EDGE and other study-specific systems, ensuring recruitment, screening, follow-up, and study activity data is recorded accurately. 
You will develop and maintain effective working relationships with research teams, clinical services, sponsors, and external