Job Overview
University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.
Detailed Job Description And Main Responsibilities
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.
- 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.
- 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 elevate participant safety concerns and adverse events in line with Trust and research governance requirements.
Coordinate Study Administration
- 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 telephone point of 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.
Person Specification
- Patient First
- Always Improving
- Working Together
Qualifications / Training Required – Essential Criteria
- Educated to ‘A’ level or equivalent
- Complete Care Certificate or NVQ3 / foundation degree in Healthcare‑related subject
- Evidence of continuing professional development
Qualifications / Training Required – Desirable Criteria
- Degree / higher education or equivalent
- IT related qualifications
- ICH‑GCP trained
Previous or Relevant Experience – Essential Criteria
- Significant relevant experience in a patient‑facing healthcare clinical role
- Administrative experience
- IT literate in Microsoft Office software (including Word and Excel)
- Experience of data management
- Advanced keyboard skills
Previous or Relevant Experience – Desirable Criteria
- Clinical research experience
- Knowledge of case note tracking, computerised patient administrative systems
- Awareness of current legislation regarding research governance issues
- Phlebotomy experience
- Acute hospital experience