Clinical Trials Assistant

University Hospital Southampton NHS Foundation Trust; Southampton; Sur place; GBP 28 000 - 38 000; Plein temps

Résumé du poste

The University Hospital Southampton NHS Foundation Trust (UHS) is seeking a Senior Clinical Trials Assistant to support the delivery of clinical research studies, direct patient care where appropriate, and administrative duties. The role involves coordinating study documentation, supporting recruitment, data collection and trial coordination to ensure compliance with GCP and Trust policies.

You will work within the Trustwide Research Team, assisting with setup, data management and monitoring

Qualifications

• Experience in healthcare, research administration or clinical trials support.
• Ability to maintain accurate study documentation and regulatory compliance.
• Strong organisational and communication skills.

Responsabilités

• Coordinate and maintain Investigator Site Files and trial master file documentation.
• Support participant recruitment, data collection and entry within study timelines.
• Assist with monitoring visits, audits and data queries from sponsors.
• Provide day-to-day guidance to junior administrative staff within the research team.
• Support delivery of a diverse portfolio of clinical studies across specialties.

Connaissances

Clinical research

Coordination

Data entry

Communication

Outils

EDGE system

CRF data capture

Description du poste

As part of our team, you will assist in the delivery of clinical research studies including direct patient care and administrative support.

Organise own workload which includes the day to day coordination and implementation of delegated studies.

Develop and maintain clinical knowledge and skills, within the scope of the role, to provide a high standard of care to participants and volunteers participating in research.

Deliver direct care to participants within scope of competence, coordinate and undertake a range of clinical tasks and observations including but not limited to venesection, blood pressure (manual and electronic), recording ECGs, and measuring height and weight (anthropometric measurements)., 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

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 one of the largest acute teaching Trusts in England, we offer learning and development opportunities to help you achieve the career you aspire to. UHS is rated 'Good' by the CQC and in the latest national NHS Staff Survey, we were in the top 10 acute trusts for staff engagement and for staff recommending the hospital as a place to work or receive care.

We support flexible working and will consider requests taking into account the needs of the service. UHS employees are able to access a range of NHS discounts, are entitled to a minimum of 35 days paid holiday (pro rata), and we offer a generous pension scheme.

Southampton is an attractive place to live and work situated on the south coast, with an international airport and direct trains to London. The New Forest National Park and beaches of the Jurassic coast are also right on our doorstep. The city offers living costs 30% lower than London and 17 schools rated outstanding by Ofsted.

We believe that using technology wisely shows strong time management and commitment to innovation. However, personalising your recruitment application to highlight your unique skills and experiences is crucial. Relying too heavily on generic, AI-generated content instead of drawing from your own strengths and accomplishments may lead to your application being rejected if multiple candidates present identical or similar information.