Job summary
Employer heading
Clinical Research (Nurse) Practitioner
Band 5
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Job overview
An opportunity has arisen for a Clinical Research (Nurse) Practitioner at Mersey Care NHS Foundation Trust. The post holder will be responsible for the delivery of a portfolio of clinical research studies delivered across the Mersey Care NHS Foundation Trust footprint. The post holder will work collaboratively with the Research and Development Manager, Study Principal Investigators and other members of the research team, to assist with the achievement of local and national targets in relation to research delivery and maintain key working relationships with the NIHR Clinical Research Network and research sponsors.
Applicants will have experience of working with research/ clinical trials, possess good interpersonal and communication skills and be able to work independently and as part of a team.
Shortlisting proposed for: 1 November 2024
Interview proposed for: 12 November 2024
Main duties of the job
The post holder will work with the Associate Medical Director for Research, Research and Development Manager, study Principal Investigators, NIHR Clinical Research Network and Trust research department colleagues in order to develop and maintain the research infrastructure which supports the recruitment of participants to both commercial and non-commercial studies, coordination of participants in studies and the collection of research data.
Working for our organisation
Mersey Care is one of the largest trusts providing physical health and mental health services in the North West, serving more than 1.4 million people across our region and are also commissioned for services that cover the North West, North Wales and the Midlands.
We offer specialist inpatient and community services that support physical and mental health and specialist inpatient mental health, learning disability, addiction and brain injury services. Mersey Care is one of only three trusts in the UK that offer high secure mental health facilities.
At the heart of all we do is our commitment to ‘perfect care’ – care that is safe, effective, positively experienced, timely, equitable and efficient. We support our staff to do the best job they can and work alongside service users, their families, and carers to design and develop future services together. We’re currently delivering a programme of organisational and service transformation to significantly improve the quality of the services we provide and safely reduce cost as we do so.
Flexible working requests will be considered for all roles.
Detailed job description and main responsibilities
Identify and recruit service users into clinical studies, acting as a source of information and support to service users and their relatives by explaining practical aspects of participating in clinical research
Ensure that each person fulfils the relevant study criteria and understands the implication of participation when taking informed consent
Demonstrate knowledge of the ethical principles for clinical research and its impact on current practice
Ensure ethical and clinical safe practice at all times
Ensure that each study is conducted in accordance with the study protocol, Trust Standard Operating Procedures and relevant research legislation and guidance
Provide direct patient care within the scope of the study protocol, including (but not limited to) physical observations, ECGs and phlebotomy where required
Process and ship blood and other samples as required in the study protocol, ensuring save and appropriate storage and handling of specimens in line with Trust policy and IATA guidelines
Provide appropriate information and support concerning research, care and treatment of individuals participating in research studies to any nursing and/or support staff involved in the participant’s care
Liaise with Principal Investigators, support services (e.g. pharmacy, radiology, laboratories), study sponsors, clinical research associates and other members of the study team, to ensure smooth running of the study
Provide research information to medical, nursing staff, service users, General Practitioners, community services and other staff where appropriate
Take a proactive role to increase Trust participation in portfolio research and recruitment rates in individual studies
Responsible for timely, accurate and complete documentation in the participants care record and the study case report form (CRF) in accordance with Trust policy and regulations
Record and report adverse events, serious adverse events and suspected, unexpected, serious adverse reactions (SUSARs) that may occur during the course of the study, to relevant personnel and act as defined within the study protocol and according to Trust policy and ICH-GCP recommendations
Assist with the coordination of study visits, in line with protocol window requirements
Assist with the set-up, undertaking, and close of each research study as required
Assist with the identification of strategies to recruit participants into research studies
Assist with identifying barriers to recruitment and ensure that the R&D Manager and Principal Investigators are aware where this has the potential to impact on study delivery targets
Ensure that all research documentation, including screening, recruitment and regulatory records are complete and accurately maintained
Provide information to allow for invoices to be raised for payment where appropriate
Comply with organisational policy on documenting critical incidents and near misses and assist with root cause analysis and the implementation of changes in practice to reduce risk
Prepare for and participate in internal audits and inspections, evaluations and benchmarking exercises
Prepare and make available study documentation for monitoring audits and inspections as required by the Trust and associated regulatory bodies
Ensure the requirements of other agencies such as the National Institute for Health Research and the Medicines and Healthcare Products Regulatory Agency are followed in order to meet research governance targets, improve clinical outcomes and ensure compliance with all legislation or standards expected for research services
Monitor and provide information on research activity giving cause for concern
Act as a mentor and contribute towards the induction and orientation of junior colleagues within the department
Plan own diary in accordance with the requirements of the Trust research portfolio
Ensure an appropriate and adequate hand over during periods of leave
Please see job description for further details.
Person specification
Qualifications
Essential criteria
- Professional knowledge acquired through degree or equivalent (e.g. NMC registered nurse or registered Allied Health Professional or a degree in life science or health related discipline)
Desirable criteria
- ICH Good Clinical Practice certificate
Experience
Essential criteria
- Experience of working with service users and carers
- Experience of giving presentations to healthcare professionals
- Experience of collaborating with other agencies
- Working knowledge of legislation and guidelines relevant to clinical research (including DH Research Governance Framework for Health and Social Care; the EU Clinical Trials Directive and ICH GCP)
- Knowledge of issues relevant to the Mental Capacity Act, vulnerable adults procedures and child protection
- Knowledge of medical terminology
Desirable criteria
- Experience of recruiting participants to portfolio research including commercial trials
- Ability to undertake research and development projects and audit projects
- Knowledge of Clinical Research Networks (CRNs), their purpose and objectives
- Knowledge of terminology relating to research
Skills
Essential criteria
- Excellent written and oral communication skills
- Ability to manage own time and workload effectively
- Computer literacy, including Microsoft Word, Excel, PowerPoint and database's utilised in clinical research (e.g., EDGE)
- Meticulous and accurate data collection ability
- Computer literacy, including Microsoft Word, Excel, PowerPoint
- Ability to take initiative and work autonomously to strict deadlines
- Highly motivated and able to motivate others
Other
Essential criteria
- Demonstrate a commitment to respecting and displaying the Trust Values at all times
- Ability to travel across the Trust sites
Applicant requirements
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.
Documents to download
Further details / informal visits contact
- Name
- William Henderson
- Job title
- Clinical Research & Innovation Practitioner
- Email address
- [email protected]
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