Clinical Research Practitioner II

Transformation Unit; Greater London; Hybride; GBP 48 000 - 57 000; Plein temps

Résumé du poste

Guy’s and St Thomas’ NHS Foundation Trust seeks a Clinical Research Practitioner II (NHS AfC: Band 6) to manage a caseload of haematology trials and support participants throughout their involvement in research activity.

The post involves independent work within governance guidelines, supervising staff, and contributing to service evaluation and improvement across the Trust’s haematology portfolio in London.

Qualifications

• Good communication skills, both verbal and written.
• Understanding of research methodologies and clinical trials.
• Ability to document and report accurately with attention to detail.
• Experience with data management systems in clinical research.

Responsabilités

• Manage portfolio of Haematology clinical Trials (Phase I–III).
• Assist in reviewing study protocols and resource implications.
• Coordinate study setup and submissions to R&D departments.
• Ensure accurate CRFs and timely data queries resolution.
• Monitor recruitment and liaise with clinical teams weekly.
• Provide leadership and training within the research team.

Connaissances

Communication skills

Research methodologies

Documentation skills

Data accuracy

Analytical ability

Formation

Degree or equivalent

Data management qualification

Outils

EPIC

EDGE

Description du poste

Main area Oncology and Haematology Clinical Trial Practitioner II Grade NHS AfC: Band 6 Contract Permanent: 9am to 5pm (Mon - Fri excluding Bank Holidays) Hours Full time - 9am to 5pm (Mon - Fri excluding Bank Holidays) Job ref 196-RD575M

Employer Guy's and St Thomas' NHS Foundation Trust Employer type NHS Site Guy's Hospital Town London Salary £47,951 - £56,863 per annum inc H.C.A Salary period Yearly Closing 18/11/2026 23:59

Clinical Research Practitioner II

NHS AfC: Band 6

Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services.

Guy’s is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary’s Hospital in Sidcup. St Thomas’ has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children’s Hospital.

Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it. Our community services include health visiting, school nursing and support for families of children with long-term conditions.

Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients.

In February 2021 the Royal Brompton and Harefield joined Guy’s and St Thomas’ NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research.

We have a reputation for clinical excellence and high quality teaching and research. We are part of King’s Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King’s College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit.

Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of ‘good’. Our adult community services achieved a rating of ‘outstanding’.

The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS. We know this has a positive impact on the care provided to our patients.

We have one of the most ambitious capital investment programmes anywhere in the NHS.

Job overview

The post holder will be expected to manage a caseload of participants in a portfolio of haematology clinical research studies. They will have duty of care in supporting them and their families throughout their participation in any research activity, acting as the participants advocate at all times.

The role will include identifying suitable patients for clinical trials and to work autonomously within professional practice guidelines and within the Research Governance Framework. The post holder may need to work flexibly across disciplines to ensure the successful working of the clinical research projects they are assigned to.

Drawing on knowledge and experience they will supervise and mentor other staff 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 portfolio of Haematology clinical Trials (Phase I – III commercial and No-commercial).
• Assist in the review of research study protocols and identify resource implications for the site.
• Liaise with study set-up teams to facilitate smooth and effective study set-up.
• Assist in completing submissions to Research & Development departments.
• Process amendments and disseminate information to relevant departments.
• Participate in the collation of data, including performance data.
• Responsible for accurate and timely completion of Clinical Report Forms (CRFs) and for ensuring that all data queries are dealt with in a timely and efficient manner.
• Ensure timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
• Actively work to achieve study accrual targets including engaging with the research team and clinical teams to overcome barriers to participant enrolment.
• Monitor patient recruitment and data collection week by week, reviewing recruitment figures and alerting the lead research staff and Principal Investigators to any problems with recruitment.
• Organise and facilitate Sponsor meetings and visits, including site initiation, monitoring and close-out, representing the Trust in a professional and positive manner.

Working for our organisation

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 one of the National Institute for Health Research’s biomedical research centres, established with King’s College London in 2007, as well as dedicated clinical research facilities.

We have around 22,700 staff, making us one of the largest NHS Trusts in the country and one of the biggest employers locally.

Detailed job description and main responsibilities

The post holder will be expected to manage a caseload of participants in a portfolio of haematology clinical research studies. They will have duty of care in supporting them and their families throughout their participation in any research activity, acting as the participants advocate at all times.

The role will include identifying suitable patients for clinical trials and to work autonomously within professional practice guidelines and within the Research Governance Framework. The post holder may need to work flexibly across disciplines to ensure the successful working of the clinical research projects they are assigned to.

Clinical and communication responsibilities

• Manage a caseload of Haematology clinical trial 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 by attending clinics, departments, screening notes/consultant referral and Multidisciplinary Team (MDT) meetings.
• Participate in the informed consent process acting as a resource and support to participants and their families. For appropriate studies take informed consent and ensure on-going consent.
• Co- ordinate the research participant pathway from screening through to study closure.
• 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.
• Undertake a range of clinical tasks in line with personal competencies and as stipulated in approved study protocols such as blood pressure, temperature, respirations, questionnaires, urinalysis, weight and height, and report abnormalities or changes appropriately.
• Perform tasks requiring clinical and laboratory skills, including phlebotomy, venepuncture, biological sample preparation within clinical area and laboratories 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 and visitors 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.

Research and Portfolio Management

• Manage portfolio of Haematology clinical Trials (Phase I – III commercial and No-commercial).
• Assist in the review of research study protocols and identify resource implications for the site.
• Liaise with study set-up teams to facilitate smooth and effective study set-up.
• Assist in completing submissions to Research & Development departments.
• Process amendments and disseminate information to relevant departments.
• Participate in the collation of data, including performance data.
• Responsible for accurate and timely completion of Clinical Report Forms (CRFs) and for ensuring that all data queries are dealt with in a timely and efficient manner.
• Ensure timely information and reports to reflect recruitment of patients including timely entry to EDGE according to team processes.
• Actively work to achieve study accrual targets including engaging with the research team and clinical teams to overcome barriers to participant enrolment.
• Monitor patient recruitment and data collection week by week, reviewing recruitment figures and alerting the lead research staff and Principal Investigators to any problems with recruitment.
• Organise and facilitate Sponsor meetings and visits, including site initiation, monitoring and close-out, representing the Trust in a professional and positive manner.
• Ensure that all study documentation is effectively archived as required.
• Assist in the provision of information to allow for invoices to be raised for payments where appropriate.
• Create and maintain invoice tracking for each study in conjunction with clinical team, according to team processes as required.
• Build strong professional relationships with other departments in order to promote a good working environment integration of research and open channels of communication.
• Educate appropriate medical and nursing personnel and departments on portfolio of research studies and protocol specific requirements.
• Maintain a dialogue of progress with the Clinical Research Matron, Research Manager and research team leads.
• Participate in the presentation of research findings within the Trust research network.
• Provide cover when necessary for annual leave, study leave, sick leave.

Management and Leadership

• Provide specialist advice and training to colleagues as relevant to your role.
• Supervise, train or mentor new or more junior staff as required.
• Ensure implementation of policies and highlight changes where needed.
• Proactively make recommendations to improve the quality of service delivery.
• Report incidents in line with Trust processes and support team leaders in investigating and resolving issues.
• Act up for team leader as required.
• Act as a role model for excellence in research delivery.
• Take active role in department training programme.
• Assist with the preparation of posters/research papers for meetings, conferences or publications.
• Represent the research team at local, national and international forums.
• Participate and attend investigator meetings and conferences when required.

Education & Professional Development

• Take responsibility for identifying personal training and educational needs within the context of the service and those identified during the appraisal process.
• Contribute to updating, developing and implementing Standard Operating Procedures (SOPs).
• Act in accordance with Health Education England (HEE) Care Certificate framework standards at all times.
• Undertake an Individual Performance Review annually with your Line Manager.
• Maintain a record to reflect any training carried out pertaining to the post and ensure direct reports maintain training files.

Other responsibilities

• Act always in a manner which, promotes positive working relationships and maintains the professional image of the Trust.
• Responsibly manage the control of equipment, resources and stock through the adherence of research policies and clinical trials budgets.
• Actively seek to develop the role to take account of changing requirements of the service
• Implement and adhere to relevant regulatory requirements related to study conduct.
• Work collaboratively with colleagues across R&D, NIHR Guy’s and St Thomas’ BRC and wider Trust to facilitate the achievement of objectives and shared learning.

Person specification

Experience

• Previous experience in use of Commercial and Non-Commercial clinical trial data bases.
• Experience of working effectively within a clinical trial team.
• Previous experience in preparation for clinical trial Audits and Inspections.
• Previous experience in Performing Laboratory – sample processing.
• Able to use Hospital databases. (EPIC and EDGE).

Qualifications/ Education

• Degree or equivalent qualification.
• Evidence of continuous personal, professional and academic development.
• Experience of working with software and computer systems which has been acquired either through diploma level qualifications or equivalent.
• Qualification in Data management within clinical research.

Skills/Knowledge/ Ability

• Good communication skills, both verbal and written, in dealing with staff at all levels.
• Understanding of research methodologies including phase I – III clinical trials
• Word processing, report writing and presentation skills.
• Evidence of accuracy to detail in data collection in relation to clinical Trials.
• Able to assess and interpret clinical/non-clinical information and events in order to determine appropriate course of action.

Guy’s and St Thomas’celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study’s at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership.

Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy.

As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends.

We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual’s personalcircumstances as well the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process.

Due to recent changes inthe UK immigration rules which affect Skilled Worker Visas, Global Business Mobility, Higher Skill Level and Increased Salary Thresholds, please ensure that you are able to meet the requirements to live and work in the UK before applying. Further informationabout eligibilityis available on the UK Government website.

Your e-mail address is important to us -We communicate to all job applicants via the e-mail address which has been provided on the application form. Please ensure that you check your e-mail on a regular basis.

Employer certification / accreditation badges

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.