The Trauma and Orthopaedic Research Team was established in 2014 and works alongside the local NHS Delivery Team to provide high quality, skilled, integrated and responsive support to a growing research portfolio.

This role has been developed to work with our Trauma, Paediatric and Spinal surgical staff to identify and recruit patients into a range of national trials. The role will also support the Research Manager in Orthopaedics with the identification of new opportunities to increase the size of the current research portfolio. Our aim is to provide all Trauma and Orthopaedics with the opportunity to take part in high quality research.

Main duties of the job

• The purpose of this post is to increase the number of patients participating in clinical trials at Cardiff and Vale UHB.
• The post will contribute to the assessment and management of the care pathways for patients and carers participating in clinical trials. This will include the recruitment, education, monitoring of trial patients, the collection and documentation of accurate data.
• The post holder will be working with Lead Nurses and multidisciplinary teams within the Clinical Boards and Directorates as well as the wider research teams assisting with the management of a caseload of clinical trials patients.
• The post will assess and carry out clinical procedures for patients/participants and will be considered part of the clinical team during the participants' involvement with the study. Implementing a programme of care, providing advice and will maintain records within various settings.
• The post holder will have a specialist knowledge in research and/or clinical practice enabling the post holder to work independently e.g either previous experience as a clinical research nurse or specialist knowledge within a specific disease area meeting the service needs such as Trauma and Orthopaedics.
• As part of the Research and Development team the post holder will contribute to the efficient set up and delivery of research within the UHB contributing to the performance metrics set for the UHB.

About us

Cardiff and Vale University Health Board is one of the largest Integrated Health Boards in the UK, employing over 15,000 staff, providing over 100 specialist services. Working across 6 hospital sites, we have a diverse range of career opportunities to offer. Serving around 500,000 people living in Cardiff and the Vale of Glamorgan, we are focused on the health and care needs of our local population whilst working with our partners to develop regional services.

Our mission is Caring for People, Keeping People Well,and our vision is that every person's chance of leading a healthy life should be equal. As an organisation we are unashamedly ambitious for our population's health, rising to the challenges of today and tomorrow through our 10-year strategy, Shaping our Future Wellbeing. We are contributing to a healthier Wales with great emphasis placed on innovation and improvement, learning from around the world and leading the way in clinical research. Partnership working is strong at Cardiff and Vale, and we work closely with our staff and our community.

Cardiff, the thriving Welsh capital, is a fantastic city to live and work in with an abundance of sports, arts and cultural attractions. Situated to the west of Cardiff, the Vale of Glamorgan offers a combination of beautiful Welsh countryside and a dramatic natural coastline. Whether city life or rural living, Cardiff and the Vale offers the best of both worlds.

Job description

Job responsibilities

Clinical and Professional Responsibilities

• Working autonomously to assist in the management of a caseload of clinical trial patients, whilst working as part of a multi-disciplinary team. Maintain effective communication with patients, carers and professionals to ensure high quality service delivery.
• Manage and oversee a portfolio of research studies in Trauma and Orthopaedics.
• Training and assessing research staff as competent in line with the research competencies framework.
• Identifying suitable patients for entry into clinical trials by attending clinics (screening notes) and relevant Multi-disciplinary Team meetings. Use relevant clinical knowledge to identify patients suitable for clinical research using inclusion and exclusion criteria and utilising NHS records, visiting wards and outpatients.
• Act as a resource and role model for all aspects of research clinical practice in order to optimise patient care and clinical practice.

• Carry out physical assessments, taking blood/urine samples and processing according to protocol.

• Ensure the environment is suitable for patient care and research processes, recognising the importance of privacy, dignity and diversity.
• Responsible for the care of research participants within the relevant sphere of practice and use opportunities to provide health promotion and patient education.
• Facilitate recruitment into a number of research studies ensuring all study timelines are met.
• Maintain accurate documentation of patient events in nursing/medical notes and Case Report Forms.
• Demonstrate a comprehensive understanding of treatment options, treatment side effects and disease processes to support patients in making an informed choice.
• Provide ongoing information, education and support to patients (and their significant others) regarding clinical trials and specific trial treatments and procedures.
• Ensure that research specific investigations are undertaken as required by the protocol and obtain results in order to establish eligibility and safety to enter the research study.
• Safely administer the treatments and drugs that are given within the context of a clinical trial.

• Assess and manage any adverse reactions occurring due to ongoing treatment of a participant in a study seeking advice from Specialist nurses as appropriate and when required. Initiate changes to treatments or treatment cessation in accordance to the protocol and with advice from a clinician.
• Ensuring all reactions are captured in the appropriate documentation.

• Provide continuity of care to patients and their carers throughout the research study. Provide specific advice and support as appropriate. Refer to other specialists as required to ensure optimum patient care.
• Maintain accurate patient data, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes
• Contribute to the monitoring of clinical standards within the research team.
• Work within NMC Code demonstrating accountability for own actions and awareness of own limitations.
• Utilise Information Governance guidance for the handling of sensitive patient data.
• Develop additional clinical skills to meet the needs of individual studies.
• Provide line management for band 5 research nurses/research officers within the research team. Monitor leave requests and other absences to ensure agreed manpower and skill mix are available to maintain the safe and effective running of research studies
• Responsible for teaching and delivering core training on competencies within research delivery.

Research

• Be responsible for the delivery of allocated research studies. Oversee studies allocated to band 5 research nurses/research officers.
• Ensure that the delivery of studies meet requirements with regards to the UK policy framework for health and social care research and the EU Clinical Trials Directive by implementing quality systems.
• Participate in Good Clinical Practice (GCP) training, keeping up to date with any changes in legislation or practice.
• Contribute to the Expression of Interest / Study Selection process
• Contribute to study set up, recruitment planning and study delivery.
• Be responsible for promoting the appropriate referral and recruitment of patients to clinical research studies. Work with research teams and investigators to develop strategies to overcome barriers to recruitment and to solve other problems relating to specific studies.
• Coordinate and run study visits including off site visits whilst adhering to the lone worker policy.
• Work with other departments within the UHB to ensure that research specific investigations and procedures are undertaken as required by the protocol, in order to establish eligibility and safety of patients within research.
• Ensure clear, accurate and concise records are kept for research projects in accordance with all regulatory requirements including the Data Protection Act.
• Ensure that data is transcribed accurately where required and assist with the maintenance of the Trial Master File.
• Respond to data queries generated by the study coordinating team within a timely manner.
• Ensure the recording & reporting of adverse and serious adverse events that occur whilst the participant is in the research study to the study co-coordinator/Principal Investigator (PI) and R& D office in line with the study protocol, local policies and regulatory requirements.
• Assess and evaluate the progress of on-going studies, maintaining accurate records of the status of studies and providing regular updates to the department on the status of the studies. This will involve ensuring that the Local Patient Management System (LPMS) is updated with key study data and validated efficiently.
• Escalate on-going study performance issues to the Senior Research Nurse/Team Lead.
• Co-operate with external and internal audit, data monitoring and quality assurance by working with R& D, sponsors, study monitors and external bodies.
• Assist with study close down and the preparation of results of research for presentation as posters, abstracts, papers or scientific presentations.

Professional Development and Education

• Attend relevant meetings and provide regular research progress reports. These reports will influence actions and decision on future research. The post holder will contribute to the development of new research proposals as appropriate.
• Required to keep up to date with policy developments especially in Welsh Government and NIHR (UK).
• Mentor new research delivery staff internal and external to R& D and provide clinical supervision to staff and students.
• Whilst the post holder will work within specific research study protocols and guidelines it is essential for the post-holder to work on her/his own initiative, demonstrate a flexible approach to work and to function well as part of the Research Delivery Team within the UHB. The post holder will need to provide professional leadership on research when talking to clinical teams.
• Advocate for research and will provide education and training on research projects to interested parties as required.

Quality

• Support and participate in study audits within research and development actively feeding back on lessons learnt and improving the service provided.
• Participate in task and finish groups developed through the UHB and Health and Care Research Wales, evaluating work to positively introduce change.
• Feedback on pharmaceutical and sponsor monitoring visits in research and distributing any lessons learnt at team meetings.
• Ensure all staff adhere to relevant legislation including the UK policy framework for health and social care research and ICH GCP.

Information, Finances and Physical Resources

• Responsible for reporting defective equipment to relevant department.
• Observe personal duty of care in relation to equipment and resources used in course of work.
• Advise where appropriate on the cost recovery required for commercial trial resource allocation.
• May be required to deliver presentations to clinical teams which will involve standing for periods of time.
• Be able to access and interpret information on the Open Data Platform for Research.
• Requirement to use a keyboard and VDU equipment on a daily basis.

Person Specification

Qualifications

Essential

• Registered Nurse - Current registration with NMC
• Specialist knowledge of research legislation, GCP and National Framework or equivalent demonstrable knowledge within a required disease site e.g. Trauma and Orthopaedics
• Knowledge of clinical and Research Terminology
• Ability to make independent decisions and advise others on appropriate action.

Experience

Essential

• Evidence of previous patient/client and Multi Disciplinary Team contact within work environment.
• Experience of undertaking clinical research and/or extensive clinical experience in a specific area

Skills

Essential

• Ability to communicate complex information to patients/carers/ members of MDT
• Well organised and able to plan own workload.

Employer details

Employer name

Cardiff and Vale University Health Board
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001-NMR566-1123