Overview
Senior Clinical Trials Assistant role at University Hospital Southampton NHS Foundation Trust. The post supports the Cystic Fibrosis (CF) and Bronchiectasis Research Team within the Clinical Research Facility. This role involves delivering high-quality clinical research studies, supporting participants and the multidisciplinary research team, and developing clinical knowledge to provide a high standard of participant care. UHS is committed to a flexible working environment, diversity, inclusion, and an anti-racist, anti-discriminatory workplace where everyone can belong, thrive, and contribute.
Main responsibilities
* 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, and anthropometric measurements (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 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, data entry and data queries, and contributing to the setup and delivery of new studies.
* Arrange shipment of biological samples, data, and equipment nationally and internationally; maintain stock levels of study consumables with correct storage and timely replenishment.
* Act as first point of telephone contact for research enquiries and support monitoring visits.
* Maintain a clean, safe, and secure environment for participants and staff; develop and promote effective working relationships within a multidisciplinary team; support junior staff where appropriate.
* Recognise professional boundaries, escalate concerns, and undertake training to maintain competence; participate in and deliver staff training; provide a flexible service to meet participant, study, and service needs (including 24/7 working as required).
* Act as a role model and ambassador for clinical research and promote high standards of participant care.
Qualifications and Training
Essential criteria
* Educated to A level or equivalent
* Complete Care Certificate or NVQ3/foundation degree in a healthcare-related subject
* Evidence of continuing professional development
Desirable criteria
* Degree or 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 (Word and Excel)
* Experience of data management
* Advanced keyboard skills
Desirable criteria
* Clinical research experience
* Knowledge of case note tracking or computerised patient administrative systems
* Awareness of current legislation regarding research governance
* Phlebotomy experience
* Acute hospital experience
Seniority and Employment
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Research, Analyst, and Information Technology
* Industries: Hospitals and Health Care
Location mentions Portsmouth/Southampton and general recruitment context are included for informational purposes.
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