Job overview
An exciting opportunity has arisen for dynamic, motivated individual to support the further expansion of ground breaking research being conducted in the West of England. The successful candidate will facilitate the equitable access to clinical trials that will support the health and wellbeing of individuals and the wider public into the future. In collaboration with our partners, our vision is deliver high quality, robust research that places Bristol at the heart of pioneering developments in public health. The V&T research team have successfully delivered a number of large scale clinical trials and are seeking an individual with a can do attitude to support the continued delivery of this important research.
Main duties of the job
The Vaccine and Testing (V&T) Senior Research Nurse is expected to support the management and leadership of the research nurses and administrative staff within the research team. S/he will have knowledge and understanding of the regulatory and legal frameworks related to the planning, undertaking and closure of clinical research studies, including Clinical Trials of Investigational Medicinal Products and therefore acts as a resource for staff, researchers, research participants and patients. S/he will take a lead in ensuring the safe and effective delivery of a number of clinical research studies including, but not limited to, the IBHO study.
The Vaccine and Testing research team will lead on supporting Principal Investigators (PI) in the setup and delivery of vaccine and testing research, including and prioritising urgent public health research. The research will be based at the Clinical Research Facility, a purpose built research delivery centre.
The V&T Senior Research Nurse will report to the V&T Research Sister/Charge Nurse and the team will be part of the division of Trust Services, allowing flexibility to work across the trust and with all clinical divisions. Research studies are delivered within the trust across seven days of the week and throughout 24 hours of each day, and therefore research nurses should be flexible in their work patterns in order to deliver this service if the studies require.
Working for our organisation
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) is one of the largest acute Trusts in the country, bringing together a combined workforce of over 13,000 staff and over 100 different clinical services across 10 different sites, serving a core population of more than 500,000 people across South West England. UHBW has been rated by the CQC as ‘Good’ overall and our staff are proud to deliver excellent care to the people of Bristol, Weston and beyond. As a forward- thinking multi-award winning Trust and a digital exemplar committed to improving patient care, our world-leading research and innovations are having a positive local and global impact. Our hospitals are spread across Bristol and Weston, join us and you can enjoy the very best of both worlds; city living within a stone’s throw of the countryside or beside the seaside, both with easy access to all that the South West has to offer. UHBW is committed to safeguarding and promoting the welfare of children, young people and vulnerable adults. As an equal opportunities employer actively working towards a diverse workforce we aim to recruit and retain a workforce which represents the rich diversity of the local population at all levels and are committed to designing our services around the needs of individual patients and those around them. Anonymous information will be used from your application in order to ensure we’re meeting our pledge.
Detailed job description and main responsibilities
Unit Management
· Manage a designated number of research studies
· Maintain a safe environment, for patients, staff and visitors, ensuring that all control measures comply with the UHBW current policies and procedures, and any statutory requirements, including all Health and Safety and Clinical Governance arrangements
· Use judgment in relation to competing demands for funding, staff and team resources
· Contribute to the control of the research unit budget ensuring that adequate measures exist for delivery of the research studies
· Respond to change in line with the needs of service provision
· Support the development and updating of team’s policies and procedures
· Ensure that all record keeping within the department is appropriate, timely and clearly understood for the purpose of patient care, safety and data integrity
· Work closely with and negotiate with research unit leads across all divisions to fill rotas to deliver Urgent Public Health vaccine and testing research at short notice.
Staff Management
· Maintain standards of practice in accordance with the legal rules and statutory regulations set out by the NMC or appropriate professional body
· Support the professional and educational development of research team’s nursing, allied health professional and administrative staff, assisting in identifying needs and finding solutions
· Support the training and ensure the appropriate supervision of research team’s staff, contributing to their mentorship and monitoring
· Line manage research nurses within the team as and when agreed
· Assist with the recruitment, selection, induction and orientation for new research nursing, allied health professional and administrative staff
· Facilitate the team working effectively and cohesively together, developing the relevant clinical skills, delivering studies to time and target
· Provide day to day management of the research team in the absence of the Research Sister/Charge Nurse, ensuring all staff and activities comply with trust policies and guidelines
· To act as a role model in establishing good practice and establishing standards of care and management that should be adhered to 24hrs a day
· Responsible for effective communication within the nursing teams ensuring that all members are well briefed on key Divisional and corporate issues
· Promote an approach to patients focussed on care and compassion, ensuring courtesy and respect at all times
· Ensure that standard operating procedures are followed by all members of the research team
Study Set Up
· Ensure all elements of set up are completed in accordance with UK and EU legal requirements, Trust policies and ICH-GCP or IS0 14155, as appropriate, whether conducted personally or through appropriate delegation.
· Provide advice and guidance on matters relating to research ethics and governance and in preparing submissions for regulatory and trust approval.
· Have a detailed knowledge and understanding of research design and methodology
· Contribute to the assessment of study protocols and advise on any safety, regulatory and logistical issues
· Provide oversight for the set-up of a designated number of research studies within the team, acting as point of contact for R&I in the feasibility process
· Project manage study set up with colleagues from around the trust (support departments, finance etc) and within the University of Bristol (academic studies)
Study Conduct
· Support local Principal Investigators in meeting their responsibilities outlined in regulatory and legal frameworks
· Support colleagues and researchers through the research study process, including the delivery of clinical aspects associated with the research study
· Ensure that processes and procedures for ensuring participant confidentiality are developed and adhered to in compliance with the Data Protection Act and Caldicott regulations.
· Identify & screen appropriate study participants, in accordance with the protocol, & in conjunction with other members of the clinical & research team
· Take informed consent for designated research studies as agreed within the protocol
· Provide knowledge and demonstrate accurate attention to detail in documentation tasks, to include:
*
o Investigator Site File maintenance
o CRF completion
o Documenting source data
· Contribute to the auditing and monitoring of research studies; respond to recommendations ensuring outcomes are shared within the division and wider UHBW research community as appropriate.
· Act as a resource to PIs in ensuring all Adverse Events and Serious Adverse Events are reported in line with ICH-GCP, ISO 14155 and UHBW Adverse Events Reporting policy
Where appropriate, liaise with the R&I department in identifying any blockages to recruitment and the running of the study; support the study
· team in developing strategies to mitigate them
· Support the study team in ensuring all reporting to regulatory bodies, R&I and Research Networks (if applicable) is done in a timely manner
· Support the study team to ensure that all equipment used is appropriately checked and calibrated with supporting documentation retained
· Liaise with Sponsors to ensure all arrangements for research governance for each study are in place
Study End
· Ensure all data clarification issues are resolved quickly
· Manage the archiving of study related documentation in line with the Trial Agreement and ICH-GCP / Medicines for Human Use (Clinical Trials) Regulations as appropriate.
· Where appropriate, ensure a smooth transition from the research pathway back to the conventional treatment pathway
Education
· Identify own learning needs and proactively seek educational opportunities to fulfil them
· Develop skills in accordance with the UHBW Competency Framework for research delivery staff appropriate to the Band 6 role
Strategic Role
· Be a champion of clinical research
· Support and influence the embedding of clinical research within the division
· Foster good relationships with key division research leads / support departments / Institutes and partners to promote the efficient running of clinical trials and develop the division research portfolio
· Contribute to the development and updating of research policies and procedures within UHBW
· Take an active role in the activities of professional forums and networks
· Disseminate the results of research into clinical nursing practice
Person specification
Qualifications and Training
Essential criteria
* Registered Nurse level 1 (Adult) with current NMC
* ICH GCP training
* Evidence of continuing professional development
Desirable criteria
* Undergraduate degree in Nursing, Science or Health related discipline
* Evidence of immunisation training appropriate to the role
* Post graduate qualification in research
* Teaching qualification
Knowledge and Experience
Essential criteria
* Excellent knowledge of Microsoft Office applications and willingness to develop technological computer skills further
* Experience working with hard to reach groups
* Knowledge of Data Protection Act 2018 and Caldicott principles
* Knowledge of the regulatory and legal frameworks related to undertaking clinical research
* Clinical, organisational and management experience
* Research nursing experience
* Broad knowledge and experience of clinical nursing practice within an acute hospital environment
Desirable criteria
* Knowledge of research design and methodology
* Project management experience
* Experience of working on vaccine and/or testing research
Skills and Abilities
Essential criteria
* Good interpersonal and communication skills
* Broad range of clinical nursing skills
* Evidence of good teamwork skills
* Good report writing, a focus on accuracy and meticulous attention to detail
* Ability to prioritise ensuring effective and efficient workload completion
Desirable criteria
* Budgetary and resource management skills
We hope that you will decide to join us and become part of this exciting journey, helping us to shape our future together.
· As an equal opportunities employer actively working towards a diverse workforce we aim to recruit and retain a workforce which represents the rich diversity of the local population at all levels and are committed to designing our services around the needs of individual patients and those around them. Anonymous information will be used from your application to ensure we’re meeting our pledge.
· The Trust is committed to investing in and caring for all our staff. We will support you in maintaining and improving your health and wellbeing, as well as your career development through management and training support - developing exceptional people for exceptional careers.
· UHBW is committed to safeguarding and promoting the welfare of children, young people, and vulnerable adults.
· To comply with Part 7 of the Immigration Act 2016 all applicants must be able to speak fluent English to an appropriate standard which will be assessed at Interview.
· If you require sponsorship for a visa to work in the UK, to avoid disappointment, please check to ensure you are eligible under the UKVI points based system.
· The Trust uses electronic new starter forms on Trac to collect personal details. Information collected is securely stored and used to set up the employee record on the ESR HR system.
· By applying for this post, you are agreeing to University Hospitals Bristol and Weston NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job, information will also be transferred into the national NHS Electronic Staff Records system.
· Please be aware of scams – unless specified above, we will only communicate with you via @recruit.trac.jobs or nhs.net e-mails and we will never ask you for any payments.
IMPORTANT:
Please note that if you apply for a position with this Trust, you may be contacted via Trac or via email. This includes invites for job interviews. We therefore recommend that you regularly check your Trac account and email accounts. We may also contact you by texting the mobile number, if provided, on the application form.
Due to the high number of applications that are received for some posts we may close this vacancy before the advertised closing date. Therefore, please apply for this post as soon as you can, if you are interested and you meet the requirements of the Person Specification
Only those candidates who clearly demonstrate how they meet the person specification will be shortlisted for this job.
As a guide interviews should usually take place within 3 weeks of the closing date.
When providing employment reference details, please provide correct work-related email addresses so references can be sought promptly when we are looking to progress your application. Your referee must all be known to you in a line manager or professional lead capacity.