Senior Clinical Trials Assistant

University Hospital Southampton; Southampton; On-site; GBP 25,000 - 35,000; Full time

Job summary

A leading healthcare institution in Southampton is seeking a Senior Clinical Trials Assistant to support high-quality clinical research studies. The candidate will assist in delivering clinical research, providing patient care, and coordinating administrative tasks. Essential qualifications include A-levels or equivalent and relevant healthcare experience. This role involves working closely with clinical teams and requires strong IT and communication skills, as well as administrative capabilities.

Qualifications

• Educated to 'A' level or equivalent.
• Complete Care Certificate or NVQ3 in a healthcare-related subject.
• Significant experience in a patient-facing healthcare role.

Responsibilities

• Assist in the delivery of clinical research studies.
• Coordinate and implement delegated studies.
• Organize and manage own workload for efficient study delivery.

Skills

Patient care

Data management

IT literacy in Microsoft Office

Communication skills

Education

A level or equivalent

Healthcare-related degree or NVQ3

Tools

Microsoft Word

Microsoft Excel

Job description

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