Senior Clinical Research Practitioner
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
Exciting Opportunity: Senior Clinical Research Practitioner – Cardiac Pillar, Rossini Platform Trial
Are you an enthusiastic and motivated individual looking to develop your research career? Join us as a Senior Clinical Research Practitioner and be part of the largest surgical trial in the UK—the Rossini-Platform trial. This is a unique opportunity to expand your expertise, contribute to ground-breaking research, and enhance your professional network both within the Trust and across the UK.
Main duties of the job
In this dynamic role, you will work across multiple sites, driving recruitment and supporting the successful rollout of this innovative multi-arm, multi-stage (MAMS) trial. You will play a key role in site engagement, training, compliance, and dissemination of best practices, while also improving collaboration between research teams.This role offers a perfect blend of clinical and managerial responsibilities, allowing you to autonomously manage a caseload of participants while mentoring and supporting staff. If you are passionate about research excellence and improving patient outcomes, we would love to hear from you.
This role is for 1.0 FTE for 1 year, fixed term 0.5FTE for 2 years contract can also be considered.
Working for our organisation
The Surveillance and Innovation Unit (SUI) is a new unit in the Directorate of Infection. The Senior Clinical Research Practitioner team will work within in the Surveillance and Innovation Unit, which is a dynamic, friendly team covering Surgical Site Infection Surveillance across the trust and in the community.
Previous candidates need not apply.
Detailed job description and main responsibilities
Clinical and Communication Responsibilities
Work autonomously to manage a large caseload of participants acting as a professional in ensuring a duty of care to the participants and their families.
Work within relevant regulations and ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical research protocol is adhered to at all times.
Devise, implement and evaluate strategies to identify eligible participants for the ROSSINI-Platform, including attending appropriate clinical meetings, disseminating knowledge and awareness of the trial amongst peers and relevant parties nationally.Support multiple sites to implement those strategies, with travel required to sites.
Participate in the informed consent process acting as a resource and support to sites and participants and their families.
Participate and support co-ordination of the relevant patient participation groups. Review and act on or feedback to the pillar and core teams relevant feedback from groups.
Coordinate the research participant pathway from screening for recruitment through to study closure.
Actively work to achieve study site and patient recruitment targets including engaging with the research team and site clinical teams to overcome barriers to participant enrolment.
Liaise with the clinical team to organise and ensure that study specific investigations are undertaken according to the protocol, obtain and document the results.
Deal with concerns raised by participants and visitors in a proactive manner and take appropriate remedial action as necessary.
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.
Report to the governance team any clinical incidences and follow up to conclusion.
Act as a role model for excellence in research delivery.
Portfolio Management and Development
Review study protocols and identify resource implications for the sites.
Liaise with the medical team/sponsor organisation and co-ordinate follow up of participant where necessary.
Liaise with sites to ensure all site trial set-up actions have been completed.
Process amendments and disseminate information to sites.
Ensure participant recruitment data is being collected in a timely and accurate manner across sites.
Build strong professional relationships with other sites and BCTU to promote a good working environment and foster collaboration
Educate appropriate medical and nursing personnel and departments of the ROSSINI-Platform and protocol specific requirements.
Participate in the presentation of research findings and represent the ROSSINI-platform within the Trust and local Clinical Research Network, across sites and in relevant national specialty forum.
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.
Provide a monthly report of study activity and dissemination activity.
Team Management and Leadership
Act as a role model for excellence in research delivery
Lead and support the team acting as an expert resource, demonstrating tenacity, drive, professional integrity, balance and perspective.
Implement and work within the Trust’s HR policies on all staffing matters, including sickness, capability and disciplinary issues. Take corrective measures if indicated in liaison with Human Resources and the Management Team.
Provide expert clinical research support to the clinical research team at the ROSSINI-Platform partner sites
Work with the other Band 7 Team Leaders in the Surveillance & Innovation unit and other Senior Clinical Research Practitioners on the other ROSSINI-Platform arms to provide adequate clinical oversight of the project
Keep records of staff involved on each partner site is kept up to date (including professional registration details and mandatory training)
Monitor performance of partner sites and ensuring Good Clinical Practice guidelines are followed and mandatory documentation is completed to required standard for a clinical research trial
Provide assurances that staff working on the ROSSINI-Platform have undergone the required minimum training as states in the Good Clinical Practice Guidelines.
Ensure accurate and timely management of research funding
Awareness of NIHR funding & financial management of the Cardiac arm of the ROSSINI-Platform
Provide assistance of the procurement of required resources and materials at the partner sites, if needed
Be aware of all Trust procedures and policies and collaborate with other health care professionals to ensure that these are observed.
Innovate and contribute to the development of Network wide clinical and research policies and procedures.
Develop and implement strategies to maintain and increase the level of participant recruitment at partner sites for the Cardiac arm of the ROSSINI-Platform as needed
Maintain the high profile of GSTT Research and Development and the ROSSINI-platform.
Work with the management team to ensure that the Trust is meeting the accrual targets for the ROSSINI-Platform and act to address any shortfalls.
Implement strategies and systems for quality assurance and actively contribute to internal and external audits and inspections.
Attend investigator meetings and conferences when required acting as an ambassador for the ROSSINI-platform and the Trust.
Education and Professional Development
Attend the training programmes and other relevant education and training days as agreed in your development plan.
Act in accordance with care certificate framework standards at all times.
Take personal responsibility for own professional growth and keep up to date with professional development and research.
Maintain a record to reflect any training carried out pertaining to the post and ensure direct reports maintain training files.
Prepare posters/research papers for meetings, conferences and publications.
Mentor and support other members of the team.
Act up for the Trust Lead for Surveillance & Innovation as required
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 GSTT and the ROSSINI-platform to facilitate the achievement of objectives and shared learning.
Person specification
Additional Information
Essential criteria- Flexible and positive approach to work
- Enthusiastic and highly motivated within field of research
- Committed to achieving research objectives
Skills/Knowledge/Ability
Essential criteria- Excellent communication and interpersonal skills and ability to deal with complex and sensitive situations.
- Able to provide highly specialist advice to participants and clinical teams
- Awareness of changing trends in healthcare and specialist area
- Up to date knowledge relevant to clinical research and good clinical practice
- In depth understanding of research methodologies
- Working autonomously at an advanced level
- Ability to lead, teach, supervise and mentor others in relation to all aspects of clinical research delivery
- Experience of producing written reports
- Ability to lead, teach, supervise and mentor others in relation to all aspects of clinical research delivery
- Willingness and ability to attend external meetings and/or make site visits pertaining to ROSSINI-Platform
- Ability to carry out audit
Experience
Essential criteria- Significant experience in clinical research delivery including managing own portfolio of studies.
- Substantial experience relevant to speciality
- Knowledge and experience of handling complex relationships
- Experience mentoring, developing and supervising junior staff in clinical setting
- Experience in service development
- Experience of change management
- Demonstrable managerial / team lead experience
Qualifications
Essential criteria- Registered Healthcare Professional (NMC, HCPC, GPhC)
- Good Clinical Practice (GCP)
- Completed Post graduate diploma / Level 7 study in specialty or related field
- Evidence of continuous professional development
- Post graduate teaching qualification
- Registered on AHCS clinical research practitioner accredited register
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.
Flexible working
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 personal circumstances 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.
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