Clinical Research Practitioner – TREASURE study

Integrated Care System; Southampton; On-site; GBP 44,000 - 53,000; Full time

Job summary

A leading healthcare organization in Southampton is seeking a Clinical Research Practitioner for an innovative study on home self-swabbing. The role requires managing study participants, ensuring adherence to protocols, and supporting data collection and analysis. Candidates should possess relevant qualifications and significant experience in clinical research, along with excellent communication skills. This position offers a salary range of £44,485 to £52,521 based on experience.

Qualifications

• Degree in life sciences or related field or equivalent theoretical knowledge.
• Evidence of continuing professional development.
• Experience managing complex projects.

Responsibilities

• Manage study participants professionally, ensuring duty of care.
• Adhere to clinical trial protocols and ICH GCP.
• Coordinate participant journey from screening to study closure.

Skills

Excellent communication skills

Understanding of clinical research methodology

Ability to work autonomously

Ability to lead and mentor others

Knowledge of infection prevention practices

Education

Degree in life sciences or related field

GCP certificate

Registered on AHCS clinical research practitioner accredited register

Significant experience in relevant clinical research delivery setting

Job description

Go back Guy's and St Thomas' NHS Foundation Trust

Clinical Research Practitioner – TREASURE study

The closing date is 10 August 2025

TREASURE is an NIHR Research for Patient Benefit (RfPB)-funded feasibility study to explore the safety, acceptability and potential cost effectiveness of self-swabbing at home to obtain usable surgical wound culture swabs. The post holder will be expected to manage study participants at Harefield Hospital and Royal Sussex Hospital, Brighton. They will have duty of care in supporting them and their families throughout their participation in any research activity. The role will include identifying suitable patients for the clinical study, recruitment, obtaining consent, data collection, analysis and dissemination. The post holder will work autonomously within professional practice guidelines and within the Research Governance Framework. They may need to work flexibly across disciplines to ensure the successful working of the project. Drawing on knowledge and experience they will supervise and mentor other staff, act as line manager for appropriate staff if required, and actively contribute to evaluation and improvement of the service. The post holder will play a key role in ensuring that any research undertaken within the department safeguards the wellbeing of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006. In conjunction with the other members of the team, they will facilitate the production of good quality of research.

Main duties of the job

• Manage study participants professionally, ensuring duty of care to them and their families.
• Adhere to clinical trial protocols, ICH GCP, and relevant regulations.
• Develop and assess strategies to identify eligible research participants, liaising with clinical staff.
• Support and conduct the informed consent process, ensuring ongoing consent.
• Coordinate participant journey from screening to study closure.
• Collect research data via observation, interviews, case note review, and phone calls.
• Maintain accurate records in electronic medical systems and communicate with clinical teams.
• Promptly report adverse events or health concerns to appropriate medical staff and investigators.
• Perform clinical tasks such as wound assessment and swab preparation per protocols.
• Ensure safe tracking, storage, transport, and documentation of participant samples.
• Coordinate study-specific investigations and document results as per protocol.
• Report side effects and adverse events within protocol-defined timeframes.
• Act as a patient advocate.
• Escalate care deviations to senior staff and support care adjustments.
• Address participant concerns proactively and take necessary action.
• Report incidents to senior research staff and support incident and complaint management per Trust policies.
• Effectively manage clinical incidents.

About us

Guy's and St Thomas' NHS Foundation Trust comprises five of the UK's best-known hospitals - Guy's, St Thomas', Evelina London Children's Hospital, Royal Brompton and Harefield - as well as community services in Lambeth and Southwark, all with a long history of high-quality care, clinical excellence, research and innovation.

We are among the UK's busiest, most successful foundation trusts. We provide specialist care for patients including heart and lung, cancer and renal services as well as a full range of local hospital and community services for people in Lambeth and Southwark.

We have a long tradition of clinical and scientific achievement and - as part of King's Health Partners - we are one of England's eight academic health sciences centres, bringing together world-class clinical services, teaching and research.

We have around 22,700 staff, making us one of the largest NHS Trusts in the country and one of the biggest employers locally. We aim to reflect the diversity of the communities we serve and continue to develop new and existing partnerships with local people, patients, neighbouring NHS organisations, local authorities and charitable bodies and GPs.

We strive to recruit and retain the best staff as the dedication and skills of our employees lie at the heart of our organisation and ensure that our services are of the highest quality, safe and focused on our patients.

Job responsibilities

Clinical and Communication Responsibilities

• Manage study participants acting as a professional in ensuring a duty of care to the participant and their families.
• Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times.
• Devise, implement and evaluate strategies for identifying eligible participants for research studies, including liaising with clinical staff.
• Participate in the informed consent process acting as a resource and support to participants and their families. Take informed consent and ensure on-going consent.
• Co- ordinate the research participant pathway from screening through to study closure.
• Undertake research data collection through observations, interviews, case note review and phone calls.
• Maintain adequate participant records and ensure all relevant information is documented in the medical electronic notes or relevant clinical information systems and communicated with clinical teams.
• Report any adverse events or health concerns which occur whilst the participant is taking part in the study to the appropriate doctor or nurse in a timely manner, and to the appropriate principal or co-investigator.
• Perform tasks requiring clinical skills, including assessing surgical wounds for signs of infection and assisting with wound swabbing sample preparation as stipulated in approved protocols and laboratory manuals as required.
• Responsible for safe tracking, storage, efficient transport and robust documentation of participants samples.
• Liaise with the clinical team to organise and ensure that study specific investigations are undertaken according to the protocol, obtain and document the results.
• Report any side effects or adverse events according to protocol guidelines and within the required timeframe.
• Act as a patient advocate.
• Report any deviation from normal practice to senior staff and agree changes in care programme.
• Deal with concerns raised by participants in a proactive manner and take remedial action as necessary.
• Report to the senior clinical research staff any clinical incidences. Assist in managing incidents, accidents and complaints in accordance with Trust Policies.
• Manage clinical incidents effectively.

Please see job description document for full responsibilities.

Person Specification

Qualifications/ Education

• Degree in life sciences or related field or equivalent theoretical knowledge
• Post graduate diploma or equivalent theoretical knowledge relevant to field
• Evidence of continuing professional development
• GCP certificate
• Commitment to join AHCS accredited Clinical Research Practitioner register
• ILS certificate
• Registered on AHCS clinical research practitioner accredited register
• Significant experience in relevant clinical research delivery setting
• Experience managing complex projects
• Experience within speciality
• Experience in conducting interviews

Skills/Knowledge/ Ability

• Excellent communication skills and ability to deal with complex and sensitive situations
• Understanding of clinical research methodology
• Able to acquire in-depth knowledge of research protocols and communicate this to multi-disciplinary team and participants
• Ability to interpret patient records and extract data accurately
• Awareness of clinical governance and risk management relevant to the role
• Ability to work autonomously and as a member of a small team, as well as part of the wider multidisciplinary team
• Ability to co-ordinate and organise activities in order to deliver study protocol
• Confident and articulate
• Ability to lead, teach, supervise and mentor others in all aspects of clinical research delivery.
• Excellent customer care skills - ability to host and co-ordinate Sponsor visits
• Commitment to achieving objectives of the research team
• Familiar with digital platforms such as Microsoft Teams
• Knowledge of infection prevention practices

Additional information

• Flexible and positive approach to work
• Highly motivated and enthusiastic
• Willingness to travel to Brighton (occasional), if required

Physical Requirements

• Willingness and ability to travel to external meetings within the context of this post
• Able to concentrate for prolonged periods when cross-referencing medical case notes
• Frequently need to carry medical case notes from clinical areas for analysis or move equipment.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Guy's and St Thomas' NHS Foundation Trust

£44,485 to £52,521 a yearDependent on experience