- To work autonomously to manage 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 comprehensive patient records and ensure all relevant information is documented and uploaded in the patients 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 prescribed 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.
- 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 effectively archived as required in compliance with GCP principles, trust policies and study requirements.
- 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.
- 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.
- 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 significant others) fully understand the nature of the research study.
- The patient is aware that entry into the trial is voluntary and they can withdraw at any point without prejudice.
- The patient is 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 be flexible and adaptable to help other research departments as required and as own trial burden permits.
- To accurately record data on trial pro-forma, co-ordinate monitoring visits from sponsors / Clinical Research Organisations and respond promptly to data queries.
- Work within the NMC Code of 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 GCP Guidelines, the study protocol, the UK policy framework for health and social care research and any other trial manuals in order to protect the research participants and the quality of each study.
- To safeguard the interests 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
- NMC Registered General Nurse
- Valid GCP certification
- Graduate Qualification
- The relevant amount of time working in a clinical setting at Senior Band 5 or above
- Experience of working in more than one speciality
- Experience in administering and monitoring trial medications.
- Experience in setting up, recruiting to, closing down and archiving clinical trials.
- Experience of caring for patients involved in clinical trials.
- Experience of teaching, supervising and mentoring junior staff.
- A good knowledge of: 1)clinical trials process 2)regulatory clinical research frameworks
- Knowledge of the Data Protection Act and implications for confidentiality.
- Knowledge and use of the local portfolio management system - EDGE
- Excellent computer skills including Microsoft Office applications
- Capable of working with high degree of autonomy.
- Excellent communication skills to all levels of staff and patients.
- Capable of working effectively within different multidisciplinary teams.
- Accurate, legible contemporaneous documentation skills including data collection and entry
- Excellent time management
- Venepuncture
- Knowledge and use of clinical computer applications ICE iPM etc.
- Basic laboratory skills (Preparing samples Centrifuging and separating into aliquots, slide preparation.)
- Excellent team player
- Ability to establish and maintain good working relationships with all people relevant to their work.
- Ability to be proactive in problem solving and take initiative with an awareness of own limitations.
- Mental agility to competently switch between specialities, sometimes at short notice.
- Meticulous attention to detail
- Ability to work to precise protocols and deadlines
- Work under pressure
- Ability to make decisions, prioritise, organise and manage
- Able to rapidly absorb and respond to complex information.
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Generic Research Nurse - Luton, United Kingdom - Bedfordshire Hospitals NHS Foundation Trust
Description
Job summary
Join a small 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 generic research nurse at the Luton and Dunstable University Hospital. We are seeking an enthusiastic, hardworking and energetic suitably qualified person who has broad experience in a hospital setting either as a senior band 5 or band 6. You will be part of dynamic teams driving forward research across the trust; helping to promote and run research in various departments that may have no embedded research staff. 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 specialities, sometimes at short notice as the trials demand.
Main duties of the job
In the research 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 CRN. 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 in various departments. This knowledge will be key to ensure that the patients feel well cared for and supported during their research journey. The successful candidate will have a good grounding in clinical patient care. A full range of clinical skills, including venepuncture, ECG recording, sample testing as well as basic vital signs recording and height and mass measurement will be required.
You will be well supported through your research work by the departments as the role involves using an in-depth knowledge of clinical trial protocols and their application in practice. You will need a working knowledge of the local, national and international research regulations to ensure effective running of studies to research governance standards.
About us
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.
We have state-of-the art facilities placing us at the heart of cutting edge health care. The Trust continues to be committed to delivering the best patient care using the best clinical knowledge and technology available.
Please note that vacancies may close prior to the advertised closing date when sufficient number of applications have been received. Please ensure that you make your application as soon as possible.
All new staff will be subject to a probationary period covering their first six months in post. Travel between hospital sites may be required.
Please review all documents attached to this advert to ensure you familiarize yourself with all requirements of the job.
Job descriptionJob responsibilities
Job description
MAIN DUTIES & RESPONSIBILITIES
CLINICAL
MANAGEMENT AND ADMINISTRATION
EDUCATION AND TRAINING
RESEARCH AND AUDIT
PROFESSIONAL RESPONSIBILITIES
Qualifications
Essential
Desirable
Experience
Essential
Desirable
Knowledge
Essential
Desirable
Skills
Essential
Desirable
Other
Essential