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Lead Research Nurse
4 months ago
Job summary
An exciting opportunity is available to be the lead nurse on the DEXACELL (Dexamethasone as an adjunctive therapy for the management of cellulitis) research study. If you are interested in working in an innovative way and supporting teams at multiple NHS sites to deliver this study within secondary care.
DEXACELL - is looking to find out if prescribing steroid tablets alongside antibiotics improves symptoms and reduces the need for further antibiotics and healthcare visits among patients with cellulitis who attend A&E or similar NHS urgent care settings. We will involve 450 patients from approx. 15 different sites, over 17 months. Adults who come to hospital with cellulitis will be invited to take part. Those who agree will be put into one of two groups at random. One group will receive dexamethasone tablets to take for 2 days, the other group will receive placebo tablets. Both groups will also get the normal treatment for cellulitis. The study will review findings to determine the effectiveness of dexamethasone and cost-effectiveness in terms of reducing pain, improving quality of life, and reducing further antimicrobial usage and healthcare utilisation.
We are looking for an enthusiastic, willing to learn, energetic and flexible nurse to help coordinate and support the delivery of this study.
This post is dependent on grant funding so the length of contract may vary to reflect this.
Main duties of the job
DEXACELL is an exciting, and nationally important research trial taking place across at least 15 sites. The lead research nurse will act as the clinical/research lead and point of contact across all sites, promoting the study, supporting delivery and the professional development of research teams at sites, through their conduct and expertise. The post holder will be expected to support the delivery of the study nationally. They will chair regular teleconferences and/or face to face meetings with site staff to offer peer support and assistance across all the sites. With the Trial team, the lead research nurse will support site set up and initiation, acting as the delivery expert for the study. Where appropriate the lead research nurse will support the team in conducting site monitoring visits and at the end of the study assist with study close down. The lead research nurse will act as a dynamic, inspirational, and proactive leader supporting the research teams across the country to deliver their recruitment to time and target. The lead research nurse will be based at North Bristol NHS Trust (the sponsor) and will work collaboratively with the existing Emergency & Critical Care research team. They will work closely with the chief investigator and trial manager to ensure recruitment; trial retention and data quality are to a high standard on behalf of the sponsor.
About us
The role is based within the successful & friendly Research & Development (R&D) team at North Bristol NHS Trust. Working alongside the 140 plus departmental staff you will have the opportunity to network with other researchers and have access to our supportive training and development structure. The R&I team have been awarded the Investors in People Silver Award (2022-2025), making it a great place to Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialties. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally commit to treating each patient as an individual with respect and dignity, aiming to deliver excellent clinical outcomes and a first-class experience for everyone who uses our Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.
Job description
Job responsibilities
The Post holder will:
Act as an expert resource and is responsible for ensuring 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. Be responsible for ensuring the feasibility procedures undertaken are sufficient to ensure all studies undertaken are within the scope of the unit and the available resources. Will utilise expert knowledge to ensure appropriate methodologies are employed in the execution of research. Support the PI and trials team in obtaining ethical permissions, including completing IRAS / MHRA (Drug and / or devices) and local ethics submission. Be responsible for ensuring all studies are registered with the R+D department and that full Trust approval, in addition to ethics approval, has been obtained prior to commencement of the study. Work with the R+D department in contract negotiations Liaise with the NIHR Clinical Research Network throughout the study and facilitate the lines of communication between the Trust / R+D and the NIHR CRN Has a comprehensive knowledge of the financial issues relating to the undertaking of clinical research. Be expected to undertake detailed costing of studies to ensure all costs related to the study are identified prior to Trust approval being given. Involved in the financial processes associated with co-ordinating research studies and grant application. Have the ability and drive to initiate and / or undertake original research. Be responsible for project managing all the studies in set up, Is expected to identify any blockages to study set up and work with R+D to identify strategies to mitigate them. Is expected to establish and update Standard Operating Procedures and supporting the development of local and national policies for research. Ensure compilation and maintenance of all site files, in accordance with ICH-GCP. Maintain a register and documentation of ICH-GCP for all research active staff, including documentation of ongoing training pertaining to their specific studies.Clinical Trial Running
Support local Principal Investigators in meeting their responsibilities outlined in the Research Governance Framework, Medicines for Human Use (Clinical Trials) Regulations Ensure correct maintenance of Investigator Site File(s) and completion of Case Report File / eCRF with a high degree of accuracy. To understand and apply in practice the legal and regulatory requirements related to gaining and maintaining valid informed consent. This will include, where appropriate, children, young people, and vulnerable adults. Project manage the assignments to ensure all visits, observations, and interventions with the participants in accordance with the procedures and schedule of the study protocol. Acts in the best interests of the research subjects to ensure their rights are upheld. Ensure Protocol amendments are incorporated into research practice. Acts as an expert resource for staff in relation to the financial management of clinical research studies. Uses expert judgement in relation to competing demands for funding / resources Acts as an expert resource to PIs in ensuring all Adverse Events and Serious adverse events are reported in line with ICH-GCP, ISO 14155 and Trust policy. Is expected to identify any blockages to recruitment and the running of the trial and work with R+D, and where appropriate liaise with the NIHR Clinical Research Network, to identify strategies to mitigate them. Ensure that all equipment used in all the trials are appropriately calibrated and be responsible for the retention of supporting documentation. Support the PI in ensuring all reporting to regulatory bodies and Research Networks (if applicable) is done in a timely manner. Be responsible for ensuring the submission of monthly recruitment / accrual figures to the appointed person at NBT / NIHR Clinical Research Network Works within the range of research guidelines, ethical principles, and protocols, whilst adhering to organisational policies and procedures. Always observes the confidentiality of patient information, in accordance with the Data Protection Act and Caldicott regulations. Communicates to R+D / NIHR Clinical Research Network lead regarding research subjects, trial progress, workload issues and personal development. Person Specification
Education/Training/Qualifications
Essential
RGN, or equivalent health care professional, with current live registration Significant experience working at Band 6 or higher Understanding of working within an Emergency Department or Acute Medicine Evidence of continuing professional development
Desirable
Recent clinical research experience NIHR ICH-GCP
Work Experience
Essential
Experience of working within an Emergency Department or Acute Medicine Experience of establishing and managing dynamic staff teams Evidence of advanced organisational and project management skills Experience of autonomous and team working
Desirable
Experience monitoring and auditing studies to ensure they comply with all the relevant legislation Experience managing complex budgets
Knowledge/Skills/Abilities
Essential
Advanced communication skills, verbal & written, to include report writing and record keeping Presentation and influencing skills Understanding of the application of research within clinical and research governance Facilitation of the development of other staff Research knowledge Excellent organisational and time management skills with an ability to prioritise and meet deadlines A good working knowledge of the full range of Microsoft Office applications (TEAMS, Word, PowerPoint, Access, Excel, Publisher)
Desirable
Advanced knowledge of ICH-GCP inc. UK Statutory Instruments Demonstrates an appreciation of how the Trust Organisational Objectives are underpinned by research
Personal Qualities/Special Circumstances
Essential
Ability to be mobile to travel across sites to meet the needs of the post Demonstrates an ability to work autonomously while co-ordinating multiple projects