Job overview
As part of the Cardiac, Respiratory and Intensive Care Directorate, we are moving forward with our plans to co-locate our in-patient services on the Evelina campus. The primary role of the post holder will be to facilitate paediatric clinical research studies within the PICU’s at the Royal Brompton Hospital (RBH), and Evelina London Children’s Hospital sites and across the Kings Healthcare Partners Academic Health Sciences Centre. These studies will be both commercial and non-commercial, the majority of which are adopted with the NIHR-CRN Portfolio.
With the creation of Kings Health Partners Academic Health Sciences Centre Research is high on the agenda; the post holder will contribute to raising the profile of paediatric research within Paediatric Intensive Care in conjunction with the Evelina Research Team.
Main duties of the job
The primary duty of the post holder will be to work with the wider multi-disciplinary team (MDT) in conducting studies within PICU. These will include studies involving paediatric medicines and non-medicines research (for example, translational research). The PICU Research Nurse will be accountable to the PICU Research Lead Consultant, Senior PICU Research Nurse and the Evelina Paediatric Research Matron.
The function of the PICU Research Nurse is to support the clinical study service for PICU across both our hospital sites and Academic Health Sciences Centre. As the PICU Research Nurse you will be responsible for the assessment and management of care pathways for patients and carers participating in clinical studies. This will involve the recruitment, education and monitoring of children in studies and the collection of documentation of accurate data. You will work collaboratively with the clinical studies team and MDT In the management of your team’s caseload of children in clinical studies.
Working for our organisation
The PICU Research Nurse will have the opportunity to maintain PICU clinical skills with the opportunity for clinical work within the department. They have a responsibility to ensure mandatory training is updated on a yearly basis.
The role will comprise of working with parents, families and children within the paediatric and critical cares across sites. The post-holder will liaise with Matron (PICU Lead Nurse for PICU, Senior Research nurse (PICU), Head of Paediatric Research & Development, PICU Research Lead Consultant, Consultants and Junior Medical Staff, Nursing Staff, Clinical Nurse Specialists, Research Staff within the ELCH, Allied Health Professionals, Administrative and Clerical Support Staff, Professional and Technical staff; in order to coordinate and deliver studies within the local and national research portfolio.
Detailed job description and main responsibilities
Clinical
· To co-ordinate the care of clinical study participants within protocol.
· To attend multi-disciplinary meetings, and appropriate clinics, to screen and recruit new participants, and to act as a resource to the members of the MDT.
· To ensure the safe administration of treatments and drugs that are given within the context of a clinical study.
· To ensure that study specific investigations are undertaken as required by the study protocol, in order to establish eligibility and safety to enter the study.
· To provide ongoing information, education and support to children, carers and families regarding clinical studies.
· To ensure blood and other samples are collected for pharmacokinetic studies as required by the trial protocol.
· To maintain accurate documentation of clinical events.
· To accurately document data collected into the case report forms (CRF).
· To monitor treatment toxicity/side effects and initiate changes to treatment as required by the protocol.
· Be responsible for assessing and recognising emergencies in the speciality. To interpret information and take appropriate action and to lead others to do the same.
· To report and record serious adverse events that occur whilst the child is in the clinical trial to the senior research nurse, trial co-ordinator and principal investigator (PI) and relevant local personnel/regulatory authorities.
· To provide ongoing follow up care whilst the child is in the clinical study.
· To refer to other specialists as required in order to provide optimal care of the child.
· To act as a primary contact point (for study issues) for the child and family in a clinical study.
Research
· To identify strategies for recruiting children to clinical studies.
· To ensure that the portfolio of clinical study protocols are adhered to.
· To ensure that you work according to GCP and research governance standards for clinical studies.
· To facilitate the informed consent process (appropriate to age and understanding) ensuring the following is accounted for:-
1. The child (and significant others) fully understand the nature of the clinical study.
2. The child is aware that entry into the study is voluntary and they can withdraw at any point without prejudice.
3. The child is aware of any extra procedures required by the study.
4. The consent form is completed accurately and filed as required.
· To assist in forwarding study data in a timely manner to the study co-ordinating centre. Liaise with clinical study personnel outside the hospital as necessary.
· To supply data as required to senior research nurse and Paediatric Lead for Research & Development and other agencies regarding the progress of studies.
· To register/randomise children into studies.
· To identify barriers to recruitment to studies and ensure that the Senior Research nurse and Paediatric Lead for Research & Development is aware of these. Identify and implement action/plans as required.
· To provide support for clinical study colleagues in their absence.
· To attend meetings relevant to the nature of the job.
Education and Leadership
· To act as a mentor in training of Children’s Research Nurses and students.
· To ensure that students and new staff receive appropriate training and that they meet their learning objectives and competencies are signed off.
· To contribute to the development of clinical and research policies / procedures / standard operating procedures.
· To ensure that LREC, R&D approval and indemnity are in place prior to commencing the study.
· To liaise with the members of the multi - disciplinary team Pharmacists, Radiologists, Pathologists to establish procedures for the safe and smooth running of clinical studies.
· To responsibly manage the control of equipment, resources and stock through the adherence of research policies and clinical trial budgets
· To work with staff across the Academic Health Science Centre and Local Research Network to develop strategies to overcome barriers to child recruitment.
Administration
· To ensure that clinical study recruitment records are accurately maintained.
· To access the computer network as required to retrieve relevant information.
· To ensure that clinical studies are effectively archived as required.
Education and Training
· To act as a resource for colleagues in relation to all aspects of clinical studies
· To ensure that all relevant health care professionals are educated and supported as required, enabling them to care for children in clinical studies.
· To keep appropriate staff informed of the progress of clinical studies.
· To maintain an up-to-date knowledge of paediatric research related articles particularly related to clinical studies.
· To continue your own professional development, keeping updated with current practice and maintaining PREPP requirements.
· To maintain links with other clinical study nurses/practitioners across the network to develop and share knowledge and to provide mutual support.
· To attend national meetings in relation to clinical studies as appropriate and agreed with local training link.
· To maintain an awareness of current advances in paediatric treatments, research and nursing practice and uses this knowledge to maintain the highest standard of care for children.
Other
· To understand and adhere to Trust policies and procedures
· To act in accordance with the NMC Code of Professional Conduct.
· To ensure that trust wide standards are maintained and monitored to improve the quality of care to all those who come in contact with the service provided by the Trusts within the AHSC network. The post holder has responsibility for safety as outlined in the hospital’s policy and Health and Safety Work Act 1974.
· To maintain the child’s confidentiality at all times.
5. To ensure that the views of consumers are effectively sought, channelled and acted upon. This includes efficient actioning of the complaints procedure in accordance with Trust policies and in conjunction with the Network Manager.
Person specification
Research Training
Essential criteria
6. ICH GCP & EU Clinical Trial Directive Certified
7. Knowledge of research governance and regulations (ICH/GCP and EU Directives)
Desirable criteria
8. Human Tissue Act Training or Equivalent
Personal Specification
Essential criteria
9. Registered Nurse (Child)
10. Evidence of ongoing dynamic continuing professional development
11. Your professional knowledge acquired at degree level will be supplemented by specialist training, experience and short courses
12. Previous experience of research and audit
13. Experience of recruiting, educating and monitoring patients within clinical trials
14. Previous experience of change management and problem solving
15. Experience of handling clinical incidents and complaints
16. Understanding of professional and current issues in children’s nursing.
17. Knowledge of clinical trial protocols and their application in practice
Desirable criteria
18. Assessing and mentoring qualification
19. Experience of developing and implementing policies and procedures
20. Knowledge of analytical processes
21. Knowledge of research design and methodologies
22. Ability to initiate, manage and sustain change
PICU Practice and Qualification
Essential criteria
23. You will have substantial PICU experience at grade/Band 5 or 6, including within relevant clinical / research environment
24. Qualification in Specialty course KHP Critical Care Course or Relevant PICU Course
25. Able to give advice on the organization and management of the research process.
26. Understanding of resource management, health and safety, clinical risk and quality issues
27. Handling child protection issues in accordance with policy.
28. Handling clinical incidents and complaints.
29. Knowledge of clinical governance and improvement agenda
30. Ability to work independently and as part of a Multidisciplinary team.
31. Shares information and good practice appropriately.
32. Ability to organise, prioritise and co-ordinate work of self and others. Good attendance record, flexible approach to work. Effective time management
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.