Senior Clinical Trials Assistant | University Hospital NHS Foundation Trust

Senior Clinical Trials Assistant – Cystic Fibrosis & Bronchiectasis Research Team

University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.

Please see below for detailed job description of the role.

We are seeking a motivated and experienced Senior Clinical Trials Assistant to join the Cystic Fibrosis (CF) and Bronchiectasis Research Team within our Clinical Research Facility. This is an exciting opportunity to play a key role in the delivery of high-quality clinical research studies, supporting both participants and the wider multidisciplinary research team.

The post holder will assist in the delivery of clinical research studies, providing direct patient care alongside essential administrative and organisational support. You will be responsible for organising and managing your own workload, including the day-to-day coordination and implementation of delegated clinical trials, ensuring studies are conducted in line with protocols, Good Clinical Practice (GCP), and regulatory requirements.

You will be expected to develop and maintain clinical knowledge and practical skills relevant to the role, enabling you to provide a consistently high standard of care to participants and volunteers taking part in research studies. Working within your scope of competence, you will deliver direct clinical care and undertake a range of clinical tasks and observations. These will include, but are not limited to, venepuncture, manual and electronic blood pressure measurement, recording ECGs, and performing anthropometric measurements such as height and weight.

• Assist in the delivery of clinical research studies, providing direct patient care and administrative support
• Coordinate and implement delegated interventional and observational studies on a day-to-day basis
• Organise and manage own delegated workload to ensure studies are delivered efficiently and to protocol
• Deliver direct clinical care to research participants within scope of competence, including:
  • Venepuncture
  • Manual and electronic blood pressure measurement
  • ECG recording
  • Height and weight (anthropometric measurements)
• Develop and maintain clinical and research knowledge to ensure a high standard of participant care
• Undertake participant screening, eligibility checks, and informed consent where appropriately delegated
• Conduct all research activities in accordance with ICH Good Clinical Practice (GCP), legislation, local policies, and study protocols
• Identify, monitor, report, and escalate participant safety concerns and adverse events in line with Trust and research governance requirements
• Coordinate study administration including:
  • Booking and preparing participant appointments and visits
  • Arranging participant reimbursement for research visits
  • Accurately complete trial documentation, data entry, and data queries using approved participant records and IT systems
• Contribute to the set-up and delivery of new research studies
• Arrange shipment of biological samples, data, and equipment nationally and internationally
• Maintain stock levels of study consumables, ensuring correct storage and timely replenishment
• Act as the first point of telephone contact for research enquiries, providing appropriate clinical and non-clinical information within role boundaries
• Prepare for and support monitoring visits, including documentation preparation and acting as a liaison during visits
• Maintain a clean, safe, and secure environment for participants and staff
• Develop and promote effective working relationships within a multidisciplinary team
• Act as a role model and ambassador for clinical research, supporting and guiding junior staff where appropriate
• Recognise professional boundaries, escalating concerns appropriately and undertaking training to maintain competence
• Participate in and deliver staff training by sharing knowledge and experience
• Provide a flexible service, including 24/7 working as required to meet participant, study, and service needs

The successful candidate will demonstrate excellent communication and organisational skills, a patient-centred approach, and the ability to work both…