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Lead Research Nurse
2 weeks ago
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.
- 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.
- 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.
- 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
- Recent clinical research experience
- NIHR ICH-GCP
- 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
- Experience monitoring and auditing studies to ensure they comply with all the relevant legislation
- Experience managing complex budgets
- 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)
- Advanced knowledge of ICH-GCP inc. UK Statutory Instruments
- Demonstrates an appreciation of how the Trust Organisational Objectives are underpinned by research
- 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
Bristol
BS10 5NB Any attachments will be accessible after you click to apply. 339-LMG4617
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