Job overview
Join a growing, friendly department committed to developing and retaining its members of staff to maintain and further cultivate a high performing, cohesive team, the members of which enjoy coming to work and feel valued.
An exciting opportunity has arisen to join us as a paediatric research nurse at the Luton and Dunstable University Hospital. We are seeking an enthusiastic, hardworking and energetic nurse who has experience in paediatric research nursing at band 6. You will be part of a dynamic team driving forward research across the trust; helping to promote and run research in the paediatric department. You will be fully supported by the R&D team and the Principal Investigators.
The successful candidate should be well organised, be able to manage their time effectively and have the mental agility to successfully switch between trials, sometimes at short notice as the trials demand.
Main duties of the job
In the research nurse role you will work with the principal investigators from set up to closure of both commercial and academic clinical trials, all in accordance with Good Clinical Practice (GCP). You will be responsible for assessing and managing the care pathways of patients and carers participating in research studies and ensuring good communication with other members of the Department, R&D and RRDN. You will have responsibility for the delivery of direct and indirect care within your own caseload, working collaboratively with members of multi-disciplinary research teams whilst always complying with GCP.
You will need a good clinical knowledge with a desire to learn in order to work effectively. This knowledge will be key to ensure that the patients and their carers feel well cared for and supported during their research journey. The successful candidate will have a good grounding in paediatric research, including HDU. A full range of clinical skills necessary for assessing and looking after children participating in trials.
You will be well supported through your research work by the research and development department as the role involves using an in-depth knowledge of clinical trial protocols and their application in practice. You will need a thorough knowledge of the local, national and international research regulations to ensure effective running of studies to research governance standards.
Working for our organisation
Bedfordshire Hospitals NHS Foundation Trust provides hospital services to a growing population of around 700,000 people living across Bedfordshire and the surrounding areas across two busy hospital sites in Bedford and Luton. Both hospital sites offer key services such as A&E, Obstetrics-led Maternity and Paediatrics. You will be joining a friendly, high performing Trust committed to ensuring the health and wellbeing of staff. As one of the largest NHS Trusts in our region you will have access to a programme of high quality training and development to help you grow your career. The Trust continues to be committed to delivering the best patient care using the best clinical knowledge and technology available.
Our values
We not only recruit based on qualifications and experience - we recruit individuals who demonstrate the behaviours which underpin our Trusts core values. We achieve this by using values based recruitment. We are dedicated to making our recruitment practices as inclusive as possible for everyone, we are committed to promoting equality and diversity, and creating a culture that values differences.
Please note that vacancies may close prior to the advertised closing date when sufficient number of applications have been received. All new staff will be subject to a probationary period covering first 6 months in post. Travel between hospital sites may be required. Please review all documents attached to ensure you familiarize yourself with all requirements of the job
Detailed job description and main responsibilities
Job description
MAIN DUTIES & RESPONSIBILITIES
CLINICAL
To work autonomously to manage own caseload of research studies, maintaining effective communication with patients, carers and other healthcare professionals to ensure high quality service delivery.
To ensure that research study specific investigations are undertaken as required by the trial protocol in order to establish eligibility and safety to enter the trial.
To act as a resource and support to patients and carers, explaining practical aspects of research studies and working with clinical teams to map patient pathways as required.
To arrange collection of samples required as part of the research study and ensure safe and appropriate storage of specimens in conjunction with local support services staff.
To maintain adequate patient records and ensure all relevant information is documented in the patient’s healthcare records.
To be responsible for accurate and timely completion of case report forms (CRFs).
To monitor participants for toxicity/side effects and ensure that changes to treatment are effected as required by the research study protocol.
Record and report any adverse events that occur whilst the patient is in the research study to the relevant personnel and through the Trust reporting system, acting as required.
Report and record all serious adverse events, within the required time period, that occur whilst the patient is in the research study to the local Principal Investigator, research study personnel as required and through the Trust reporting system.
MANAGEMENT AND ADMINISTRATION
To ensure that research study recruitment records are accurately maintained and data contemporaneously recorded in healthcare records.
To maintain study site files and documentation.
To liaise with Trust support services as required by the research protocol to ensure safe and smooth running of the study.
To access appropriate computer systems in order to retrieve relevant information.
To ensure that research studies are archived as required in compliance with GCP principles and trust policies.
To provide information as required for the raising of invoices related to research studies.
To provide support for research colleagues and attend meetings relevant to the post.
EDUCATION AND TRAINING
To act as a resource for colleagues in relation to research studies.
To assist in the education of all relevant health care professionals to enable them to care for research study patients.
To keep all appropriate staff informed of the progress of research studies.
To keep up-to-date on research related topics in general and as appropriate to caseload and interest.
To assist in the preparation of posters for meetings and conferences both locally and at other events as required.
To assist with the education and training portfolio of the R&D Department delivering training sessions on research and research related topics as required.
RESEARCH AND AUDIT
To contribute to the management of the local portfolio of research studies and assist in the identification of research studies for introduction to research teams.
To maintain and expand understanding of research governance and the implication to research.
To identify patients eligible to enter research studies, registering and randomising patients into clinical trials as required completing pre-study tests where necessary
To facilitate the informed consent process ensuring the following is accounted for:
The patient and carers fully understand the nature of the research study.
The patient and carers are aware that entry into the trial is voluntary and they can withdraw at any point without prejudice.
The patient and carers are aware of any extra procedures required by the trial
The consent form is completed accurately and filed as required.
To be responsible for the accurate collection and inputting of research study data in a timely manner including screening of potential patients for clinical trials and evaluating eligibility.
To assist the clinical service and wider research team with the production of a research participant recruitment and retention strategy for each assigned research study.
·To accurately record data on trial pro-forma, co-ordinate monitoring visits from sponsoring companies and respond promptly to data queries.
PROFESSIONAL RESPONSIBILITIES
Work within the NMC Code of Conduct and scope of professional conduct.
Be responsible for developing and sustaining own knowledge, clinical skills and professional awareness in accordance with re-validation requirements.
Conduct the research in accordance with the relevant guidelines e.g. GCP Guidelines, the study protocol and UK policy framework for health and social care research in order to protect the research participants and the quality of each study.
To safeguard interest of patients by liaison with relevant trial personnel and contribution to trial design and protocol and ensure compliance with research guidelines.
To observe the confidentiality of participant information at all times, in accordance with the Data Protection Act 2018 and GDPR.
Person specification
Qualifications and Training
Essential criteria
1. Registered Children’s Nurse
2. Valid GCP certification
3. Successful completion of the Clinical Trials Co-ordination Certificate
4. Completion of NIHR PRES training
Desirable criteria
5. Graduate Qualification
6. Registered General Nurse
7. Completion of or enrolment on to the NIHR CREATE course
Experience
Essential criteria
8. The relevant experience working in paediatrics including high dependency experience.
9. Experience working as a paediatric research nurse in a DGH including managing multicentre trials of at least 12 months.
10. Experience of caring for patients recruited to clinical trials.
11. Experience in assessing feasibility of, setting up, recruiting to clinical trials.
12. Experience of teaching, supervising and mentoring all levels of staff.
Desirable criteria
13. Experience in administering and monitoring trial medications.
14. Experience in administering and monitoring trial medications.
Knowledge
Essential criteria
15. A thorough knowledge of: 1) clinical trials process, 2) paediatric pathways, 3) regulatory clinical research framework.s
16. Knowledge of the data protection Act (2018) and implications for confidentiality in respect of clinical trials.
17. A thorough knowledge of the consent process to clinical trials
Desirable criteria
18. Sound knowledge of paediatric referral pathways to tertiary paediatric centres.
19. Knowledge and use of the local portfolio management system – EDGE
Skills
Essential criteria
20. Experience and confidence in consenting and randomising participants to clinical trials.
21. Excellent computer skills including all Microsoft Office applications
22. Capable of working with high degree of autonomy
23. Excellent communication skills to all levels of staff and patients.
24. Capable of working effectively within multidisciplinary teams.
25. Accurate, legible contemporaneous documentation skills compliant with GCP
26. Accurate and timeous data collection and entry on paper CRFs and eCRFs.
27. Excellent time management
28. Proficiency in performing, interpreting, acting on and escalating clinical observations
Desirable criteria
29. Venepuncture
30. Basic laboratory skills (Preparing samples e.g. Centrifuging and separating into aliquots, slide preparation.)
31. ECG recording with basic interpretation knowledge.
32. Knowledge and use of local clinical computer applications e.g. ICE, iPM, Nervecentre and EVOLVE.
Other
Essential criteria
33. Ability to recognise, escalate and report adverse events in clinical trials according to the protocol and in compliance with GCP.
34. Ability to establish and maintain good working relationships with all people relevant to their work.
35. Ability to be proactive in problem solving and take initiative with an awareness of own limitations.
36. Mental agility to switch competently between trials at short notice.
37. Meticulous attention to detail
38. Ability to work to precise protocols and deadlines
39. Ability to make decisions, prioritise, organise and manage.
40. Able to rapidly absorb and respond to complex information whilst working under pressure.
41. Have the emotional resilience to support patients and carers.
Applicant requirements
You must have appropriate UK professional registration.
This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.