Clinical Research Practitioner / Research Nurse

The Royal Brompton cystic fibrosis (CF) clinical trials department comprises of clinicians, academics, allied health professionals and admin/ finance members. The Brompton adult & paediatric CF centres are made up of world leading teams carrying out global, multicentre interventional and observational studies, in both adults and children, being led by Profs Davies, Simmonds and colleagues. The Brompton is the lead site for an early-phase, multicentre trial of CFTR gene therapy led globally by Prof Eric Alton; this post has been created primarily to support this trial, whilst also working alongside the team across the CF trials portfolio.
You will be responsible for all matters relating to data collection/management, involving direct patient interactions and provision of administrative support for trial-related activities for the gene therapy study. This role requires the post holder to be able to handle a varied/extensive workload. Training will be provided in all aspects of the role.
You will support the other research taking place within the CF trials department, based at the Royal Brompton campus, close to the vibrant King's Road, Chelsea. You will be located in an office with a multidisciplinary clinical and research team allowing for networking/learning from other healthcare professionals. We encourage/support applicants in applicable career progression as a clinical research practitioner/research nurse including attendance at courses, seminars/conferences., Identify/recruit participants for research studies in CF/other inherited respiratory conditions
+ Frontline support to study participants by phone/in clinic. Demonstrate politeness, courtesy & sensitivity. Ensure enquiries are dealt with/followed up.
+ Performance & review of clinical assessments, collection/processing of participants blood or other samples
+ Maintain accurate/complete records. Always demonstrate awareness/compliance with local policies, procedures, guidelines/standards
+ Maintain up-to-date skills/knowledge in the field of CF/clinical trials. Attend national/international conferences continuing professional development. Develop areas of personal interest in healthcare
+ Contribute in the writing of research reports/publications, Your primary concern will be to maintain patient safety during the conduct of clinical studies. The post holder will be responsible for:
+ Coordination and facilitation of clinical research projects, managing them to the relevant standards.
+ Screening of case notes for recruitment of appropriate candidates and discussing with patients about the opportunity to join a relevant study.
+ Coordinating and supporting medical, nursing and technical staff to successfully complete research projects and the execution of clinical trials
+ Participation in the execution of clinical studies taking patient samples, testing prototype medical equipment, performing analysis on patient samples
+ Facilitating the research study process including scheduling patient admissions and undertaking the relevant patient assessment, investigations and treatment in accordance with the studies protocol
Being the point of contact for study participants, giving advice on the relevant study and correlated health issues
+ Ensuring that nursing/ multidisciplinary team (MDT) documentation is maintained to the Trust and GCP standards
+ Introducing improved systems of research conduct and management to enable successful project delivery
+ Ordering and purchase of equipment using online systems including interaction with University based staff and systems
+ Trust-wide clinical research polices and protocols, insuring their implementation
+ Analyse research data, ensuring consistency and accuracy. 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 and study nurse
+ Address recurrent data queries which may highlight system problems or data collection issues
+ Assist with ensuring that study equipment has the ability to download information as required by the study protocol
During research visits, specific duties will include, although not exclusively consist of:
+ Height and weight measurements
+ Collection of vital signs
+ Recording adverse events and changes in medication
+ Performing lung function, ECGs and sweat tests
+ Sputum induction and sample collection
+ Collection of breath samples
+ Obtain blood samples by venesection
+ Administration of Quality of Life questionnaires
+ Supervision of study drug dosing
Training will be provided as needed in all of the above procedures.
Communication
+ Arranging and attending team meetings
+ Writing and circulating summaries of monthly meetings as requested
+ Have an active email account and share information appropriately
+ Document all adverse incidents as required by study protocols
+ Report to local, national and international project partners as required
+ Report on the technical and clinical performance of the studies as required
+ Participate in local, national and international meetings
People management
Coordinate the participation of nursing, practitioner and medical staff to ensure the trials are completed within the project timetable
Ensure that they themselves and others involved in a study have the correct training to undertake the procedures. Ensuring that they and the team are up to date with their mandatory training
Organise own work on an ongoing basis, arranging one-off or recurring events, including training, Site Initiation Visits and Monitoring Visits
Policy and Service Development
You will be responsible for maintaining trial data to the relevant standards required for the study. This will include:
+ Maintaining Trial Master Files to Medicines and Health Regulatory Authority (MHRA) standards
+ Maintaining Investigator Site Files
+ Collating source data
+ Electronic reporting of trial data
+ Checking, filing and monitoring patient consent forms
+ Creating systems for data gathering and trial conduct such as standard operating procedures (SOPs)
+ Entering data onto database
+ Aiding statistical analysis
+ Implement the trust policies & protocols within the department
In conjunction with the lead investigator for each project and/or the senior team, you will assist with writing and make available all SOPs, policies and guidance notes that will be needed by the research team to ensure the safe conduct of the clinical trials. Trial SOPs will conform to all relevant Policies such as Infection Control, Data Protection, Human Tissue Act.
Resource management
+ Manage an inventory of consumables and equipment required for specific studies
+ Record the use of any materials expended by the group in the conduct of the trials
+ Purchase any additional equipment needed to conduct trials
+ Report expenditure accrued in the conduct of clinical trials
+ Arrange reimbursement of expenses to patients participating in research studies
+ To attend relevant meetings
+ To undertake any necessary training and/or development
Information management
Further sections
+ To ensure all mandatory training courses such as Manual handling, Fire, Resuscitation, health and safety are attended on an annual basis and the knowledge gained adhered to.
+ To abide by the Trust's core behaviours for staff and all other Trust policies including standing financial instructions, research governance, clinical governance, patient and public involvement, codes and practices, and health and safety policies
+ This job description is intended as a basic guide to the scope and responsibilities of the post and is not exhaustive. It will be subject to regular review and amendment as necessary in consultation with the post holder.
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.
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.
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Educated to degree level in a healthcare/science-related subject or have a Professional Nursing Qualification with valid NMC registration
+ Experience of working directly with patients/ study participants in a clinical setting
Good understanding of clinical terminology
+ Proven experience of organisational/record keeping/time management skills. Accurate data management, knowledge of handling confidential information. An understanding of current legislation/requirements
Excellent written & oral communication skills. Computer literate.
+ Work independently, effectively & flexibly as part of a team-unit. Cooperate in the accomplishment of departmental goals/organisational objectives

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.