Orthopaedic Research Nurse Specialist

Job Overview

We are seeking an enthusiastic and experienced Orthopaedic Research Nurse to join our dynamic team at the Luton and Dunstable University Hospital. As an Orthopaedic Research Nurse, you will play a crucial role in driving forward research across the trust, helping to promote and run research in the orthopaedic department.

Main Responsibilities

• Work autonomously to manage research studies, maintaining effective communication with patients, carers, and other healthcare professionals to ensure high-quality service delivery.
• Ensure that research study-specific investigations are undertaken as required by the trial protocol to establish eligibility and safety to enter the trial.
• 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.
• 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.
• Maintain comprehensive patient records and ensure all relevant information is documented and uploaded in the patient's healthcare records.
• Be responsible for accurate and timely completion of case report forms (CRFs).
• 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.

Management and Administration

• Ensure that research study recruitment records are accurately maintained and data contemporaneously recorded in healthcare records.
• Maintain study site files and documentation.
• Liaise with Trust support services as required by the research protocol to ensure safe and smooth running of the study.
• Access appropriate computer systems in order to retrieve relevant information.
• Ensure that research studies are effectively archived as required in compliance with GCP principles, trust policies, and study requirements.
• Provide information as required for the raising of invoices related to research studies.
• Provide support for research colleagues and attend meetings relevant to the post.

Education and Training

• Act as a resource for colleagues in relation to research studies.
• Assist in the education of all relevant health care professionals to enable them to care for research study patients.
• Keep all appropriate staff informed of the progress of research studies.
• Keep up-to-date on research-related topics in general and as appropriate to caseload and interest.
• Assist in the preparation of posters for meetings and conferences both locally and at other events as required.
• 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

• Contribute to the management of the local portfolio of research studies and assist in the identification of research studies for introduction to research teams.
• Maintain and expand understanding of research governance and the implication to research.
• Identify patients eligible to enter research studies, registering and randomising patients into clinical trials as required, completing pre-study tests where necessary.
• 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.
• 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.
• Assist the clinical service and wider research team with the production of a research participant recruitment and retention strategy for each assigned research study.
• Be flexible and adaptable to help other research departments as required and as own trial burden permits.
• 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.
• 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, i.e., 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.
• Safeguard the interests of patients by liaison with relevant trial personnel and contribution to trial design and protocol and ensure compliance with research guidelines.
• Observe the confidentiality of participant information at all times, in accordance with the Data Protection Act 2018 and GDPR.

Person Specification

Qualifications

Essential criteria

• Registered General Nurse
• Valid GCP certificate

Desirable criteria

• Graduate Qualification

Experience

Essential criteria

• The relevant experience of working in Orthopaedics

Desirable criteria

• Experience of caring for patients involved in clinical trials.
• Experience in administering and monitoring trial medications.
• Experience in setting up, recruiting to, closing down, and archiving clinical trials.
• Experience of teaching, supervising, and mentoring junior staff.

Knowledge

Essential criteria

• A good knowledge of: 1) clinical trials process 2) orthopaedic pathways 3) regulatory clinical research frameworks
• Knowledge of the data protection Act (2018) and implications for confidentiality.

Desirable criteria

• Sound knowledge of orthopaedic treatment/therapy and practice in the standard setting.
• Knowledge and use of the local portfolio management system - EDGE

Skills

Essential criteria

• Excellent computer skills including Microsoft Office applications
• Capable of working with a 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
• Proficiency in clinical observations

Desirable criteria

• Knowledge and use of clinical computer applications e.g. ICE iPM etc.
• Venepuncture
• Basic laboratory skills (Preparing samples e.g. Centrifuging and separating into aliquots, slide preparation.)

Other

Essential criteria

• 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 studies, 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.

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.

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