Guys and St Thomas is among the UKs 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.

Guys 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 Marys 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 Childrens 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 Guys 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 Kings Health Partners, one of eight accredited UK academic health sciences centres. In partnership with Kings College London we have dedicated clinical research facilities and a National Institute for Health Research (NIHR) Biomedical Research Centre.

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

Your role will be to support the research funded by the Cystic Fibrosis (CF) Trusts Clinical Trials Accelerator Platform (CTAP) (https://www.cysticfibrosis.org.uk/the-work-we-do/clinical-trials/clinical-trials-accelerator-platform). Guys & St Thomas NHS Trust/RBH has been successful in securing 1 of 6 available grants from the CTAP programme to fund a Band 7 Early Phase Trial Coordinator/Nurse post. These specialist posts focus on early phase CF trials, working alongside the existing CTAP Trial Coordinator and embedding themselves within the local clinical and research team to provide the CF community with access to early phase clinical trials.

During periods of less activity, the Early Phase Trial Coordinator/Nurse supports the CTAP Trial Coordinator with later phase CF clinical trials being delivered locally. There is also the opportunity for the Early Phase Trial Coordinator/Nurse to support other local, non-CF phase 1 clinical trials to support learning and development around early phase clinical trials.

Main duties of the job

  • Coordinate and facilitate adult and paediatric clinical research projects across cystic fibrosis
  • Independently assess patients on research studies, including the recruitment, education and monitoring of trial patients and the collection and documentation of accurate data.
  • Oversee the day-to-day conduct of early phase CF clinical trials and PICs, providing support and advice and addressing any logistical issues as they arise.
  • Working for our organisation

    The Royal Brompton Hospital is the largest CF centre in the UK and among the largest in Europe. We are a multidisciplinary group comprising clinicians, academics, allied health professionals and admin/ finance members. The trials undertaken by the group specifically target adults and children with CF. CF research at RBHT is world-leading and we are currently running a large number of clinical trials ranging from new small molecules through to antibiotic agents. 

    As well as being part of the CF Trust CTAP London network, the Imperial College/ Royal Brompton team is part of the European CF Society Clinical Trials Network (https://www.ecfs.eu/ctn). Both initiatives provide opportunities for our patients to participate in trials of new, cutting-edge medicines.

    The successful applicant will support the research based at the Royal Brompton campus, located close to the vibrant Kings Road in Chelsea. You will be located in an office with the adult MDT allowing for networking and learning from other healthcare professionals. We offer applicants time to pursue personal interests within healthcare and encourage attendance at courses, seminars and conferences.

    Detailed job description and main responsibilities

    Communication

  • Participate fully as a multi-disciplinary team member, sharing knowledge and information and supporting colleagues, to promote a cohesive team and the achievement of team objectives.
  • Demonstrate a high level of communication skills, literacy and numeracy, and extensive familiarity with Word, Excel, e-mail and web browser.
  • Develop effective professional relationships with internal and external stakeholders.
  • Use advanced communication skills to impart sensitive, complex and potentially distressing information to patients and carers, and provide them with advice and emotional support
  • To act as the first point of contact for the research team and clinical colleagues supporting the delivery of the study having regard to the data protection act/ GDPR
  • Ensure the required approvals and agreements are in place in a timely manner between GSST NHS Trust and any CF centres who will act as a Patient Identification Centre (PICs) for the trial
  • Liaise closely with the Head of the Trial Accelerator at the Cystic Fibrosis Trust to ensure on-going clinical, scientific and operational oversight.
  • Attend site initiation visits held by the Sponsor
  • Ensure all serious adverse events that occur whilst the subject is in the clinical study are recorded and reported to the principal investigator (PI) and relevant local personnel/regulatory authorities.
  • Report on the technical and clinical performance of the studies to local, national and international project partners as required
  • Promote CF Clinical Trials at scientific meetings and to prospective patients
  • Arrange and attend CF team meetings
  • Patient/customer care (both direct and indirect)

  • Be responsible for independently assessing patients and managing the study protocols for patients. Including the recruitment, education and monitoring of trial patients and the collection and documentation of accurate data.
  • Review medical notes for appropriate candidates for the relevant studies and discuss with patients about the opportunity to join a relevant study.
  • Provide and receive highly complex information in the process of explaining study involvement and gaining informed consent.
  • Facilitate studies via patient recruitment either in outpatients, on the wards or telephoning patients to arrange appointments.
  • Conduct and document measures of health status, examples include:
  • Questionnaire administration
  • Collect and process blood and other samples
  • Performance of simple and complex physiologic tests such as Spirometry, ECG and Sweat Chloride Collection
  • Administer study drugs
  • Ensure that nursing/ multidisciplinary team (MDT) documentation is maintained to the Trust and GCP standards.
  • Where necessary, support monitoring visits at your site to verify trial activities are compliant with the trial protocol, GCP and all applicable regulations.
  • Policy & Service development

  • In conjunction with the lead investigator for each project, the post holder will assist with writing and make available all SOPs, CRFs, policies and guidance notes that will be needed by the research team to ensure the safe conduct of the clinical trials.
  • Design, write and maintain study-specific documentation (case report forms) and standard operating procedure (SOPs) in consultation with members of the research team
  • Ensure trial recruitment and retention are monitored and establish procedures for dealing with any recruitment and retention problems in collaboration with the CTAP Early Phase Trial Coordinator national team
  • Participate in the collection and discussion of audit and research data as required.
  • Maintain quality control procedures for all aspects of trial conduct to ensure compliance with the principles of Good Clinical Practice, research governance standards and all applicable legislation (e.g. The Medicines for Human Use (Clinical Trials) Regulations, Data Protection Act, Good Clinical Laboratory Practice, Human Tissue Act /Human Tissue Bill (Scotland)).
  • Maintain an active awareness of developments in clinical research related laws, and suggest changes in response.
  • Resource management

  • Assist in the identification of suitable protocols, taking account of available resource, in expanding the clinical research programme portfolio by speedy and accurate completion of feasibility questionnaires.
  • Coordinate and facilitate clinical research projects across cystic fibrosis
  • Supply data regarding progress of clinical studies and projections (e.g. weekly study accrual data, GANTT charts etc).
  • Implement proper systems of documentation to enable projects to be managed to the relevant standards.
  • Ensure projects are completed to the agreed timetable and within the allocated resources
  • Identify barriers to recruitment to studies, ensure that the Lead Investigator is aware of them and implement action/plans for recruitment as required.
  • Liaise with the Clinical Engineering, Laboratory Medicine, other BRU core facilities and external companies
  • Purchase any additional equipment needed to conduct trials
  • Maintain the Investigator Site File to ensure a clear audit trail of trial activities is retained.
  • Facilitate any audit, inspection or progress visit processes required by regulatory bodies, or sponsor(s).
  • People management

  • Oversee the day-to-day conduct of early phase CF clinical trials and PICs, providing support and advice and addressing any logistical issues as they arise.
  • Coordinate the participation of nursing, physiological, biomedical, pharmaceutical and medical staff to ensure the trials are completed within the project timetable.
  • Work with local R&D departments and external R&D contacts to effectively navigate the approval processes for Early Phase Trials, including PIC agreements
  • Lead in the role out of early phase trial related training, mentorship and education to support teams from other CTAP centres to become phase 1 ready
  • Attend and complete any CF / early phase trial training requirements provided by CTAP and external parties
  • Ensure all staff are appropriately trained before undertaking trial activities and their remit is accurately reflected on the delegation of responsibilities
  • Assist in the induction and training of new research staff working on the programme ensuring they develop and maintain a sufficient level of competence
  • Information management

  • Confidently use different data entry platforms from multiple vendors for a number of clinical trials to record research data, ensuring consistency and accuracy.
  • Implement and oversee timely and efficient procedures for the collection, entry and verification of all patient data.
  • Identify key errors in data collection/entry and address or flag as necessary
  • Identify system errors in bespoke data management systems (e.g. electronic case report forms) and provide feedback to the respective team
  • Develop worksheets and databases as required for studies and ensure maintenance of the data input for the database
  • Follow Trust IT policy and comply with Data Protection Act
  • Manage the archiving of study related documentation in line with the Trial Agreement and ICH-GCP/ISO 14155
  • Coordinate collection and reporting of metric data for early phase clinical trials to the CTAP Coordinating Team at the Cystic Fibrosis Trust via the local CTAP Trial Coordinator on a quarterly basis.
  • Research and development

  • Initiate and develop audits re: research governance standards of practice and implement action plans as required.
  • Incorporate learning opportunities from existing studies to improve future study feasibility and delivery
  • Work collaboratively with the clinical trials team and the wider multi-disciplinary team in the management of caseload and development of service for clinical trial patients.
  • Undertake projects to enhance the reputation of the Trust promoting the impact that the teams research findings have throughout the region, nationally and internationally
  • Other duties

  • Be prepared to work shifts to provide night cover for hotel type overnight stays and occasional weekends
  • Undertake any other duties commensurate with the grade as requested.
  • Person specification

    Education

    Essential criteria

  • Educated to or working towards Post-Graduate Degree level or equivalent experience
  • Evidence of on-going professional development.
  • Desirable criteria

  • Specialist qualification relevant to the role.
  • Recognised qualification in teaching/mentorship or leadership/management
  • Experience and Knowledge

    Essential criteria

  • Clinical or clinical research experience
  • Interest in clinical research
  • Knowledge of Research Governance Framework (RGF), International Conference on Harmonisation/Good Clinical Practice (ICH/GCP)
  • Knowledge of current issues within acute and chronic health care
  • Desirable criteria

  • Knowledge of CF, bronchiectasis and host defence clinically and within the research environment
  • Skills & Abilities

    Essential criteria

  • Ability to work independently assessing patients participating in research.
  • Excellent interpersonal, communication, organization and time management skills.
  • Able to use initiative
  • Able to prioritise and deliver agreed objectives
  • Ability to communicate and synthesise complex information
  • Personal Qualities

    Essential criteria

  • Ability to deal with stressful situations
  • Assertive
  • Able to lead, motivate, delegate and be a good team player within a multidisciplinary team.
  • Desirable criteria

  • Proven ability to manage change
  • Other

    Essential criteria

  • Able to work some flexible hours including the occasional night duty rotation and weekend.
  • Ability to move and handle patients and equipment
  • Demonstrate clarity and breadth in use of English language
  • Guys 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 studys 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.