Job Overview
An exciting opportunity has arisen for you to join Research and Development at North Bristol NHS Trust as a Lead Research Nurse for the Breast Care Pillar of a multi‑arm, multi‑stage platform trial. You will work across sites to drive and support the recruitment and roll‑out of the ROSSINI‑Platform trial, delivering high‑quality research and clinical care within an innovative MAMS trial.
This is a fixed‑term post that will allow you to develop skills and experience for future opportunities within the department, while contributing to the largest surgical trial in the UK.
North Bristol NHS Trust has recently achieved a Silver accreditation with "Investors in People", reflecting our commitment to lead, develop and support our staff to be their best.
Main Duties
* Review trial documentation
* Support trial uptake
* Support site openings, including training and compliance for sites
* Disseminate best practice in recruitment and use of the digital wound hub
* Help with engagement and participation in the NIHR Associate Principal Investigator scheme
* Engage with trainee‑centric research collaboratives, maintain GCP training and site delegation logs
* Attend and contribute to trial management groups
* Improve interface between sites
Working for our organisation
North Bristol NHS Trust employs over 12,000 staff and provides healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award‑winning hospital at Southmead. We are the regional Major Trauma Centre and an internationally recognised centre of excellence. We value all people as individuals, aim to be an anti‑discriminatory organisation and welcome applicants from all under‑represented groups.
Detailed Job Description And Main Responsibilities
* Act as an expert resource ensuring all elements of set up are completed in accordance with UK and EU legal requirements, Trust policies and ICH‑GCP or ISO 14155
* Ensure feasibility procedures are sufficient and studies remain within scope and resources
* Utilise expert knowledge to employ appropriate methodologies in research execution
* Support the PI and trials team in obtaining ethical permissions, including IRAS/MHRA and local ethics submission
* Ensure all studies are registered with the R+D department and gain full Trust approval before commencement
* Work with the R+D department in contract negotiations and liaise with the NIHR RRDN throughout the study
* Maintain comprehensive knowledge of financial issues relating to clinical research and undertake detailed costing before Trust approval
* Coordinate research studies and grant application financial processes
* Initiate and/or undertake original research where appropriate
* Project‑manage all studies in set‑up and identify/blockage mitigation strategies
* Establish and update SOPs and support development of local and national research policies
* Compile and maintain all site files in accordance with ICH‑GCP
* Maintain a register and documentation of ICH‑GCP for all active research staff, including ongoing training records
Clinical Trial Running
* Support local PIs in meeting responsibilities outlined by the Research Governance Framework and the Medicines for Human Use (Clinical Trials) Regulations
* Ensure correct maintenance of Investigator Site Files and completion of Case Report Forms/eCRFs
* Apply legal and regulatory requirements to in‑formed consent, including for children, young people, and vulnerable adults
* Project‑manage assignments to ensure all visits, observations, and interventions align with protocol and schedule
* Act in the best interests of research subjects, upholding their rights
* Ensure protocol amendments are incorporated into research practice
* Provide expert judgement on financial management of clinical research studies
* Report adverse events and serious adverse events in line with ICH‑GCP, ISO 14155 and Trust policy
* Identify and mitigate blockages to recruitment and trial running, liaising with R+D and NIHR RRDN as needed
* Ensure all equipment is calibrated and documentation retained
* Support the PI in timely regulatory and network reporting
* Submit monthly recruitment/accrual figures to the appointed person at NBT/NIHR RRDN
* Observe confidentiality of patient information per Data Protection Act and Caldicott regulations
* Communicate trial progress, workload issues and personal development with R&D/NIHR RRDN lead
Person Specification
Education/Training/Qualifications
Essential criteria
* RGN with current live registration
* 2 years experience at band 6 or higher in Breast Care or Surgical research delivery
* Broad clinical knowledge (surgical/breast care)
Desirable criteria
* Postgraduate level 7 (or working towards)
* Evidence of leadership development training
Work Experience
Essential criteria
* Experience establishing and managing dynamic staff teams
* Evidence of advanced organisational and project management skills
* Experience of autonomous and team working
Desirable criteria
* Experience monitoring and auditing to ensure compliance with legislation
* Experience managing complex budgets
Knowledge/Skills/Abilities
Essential criteria
* Advanced communication skills, verbal & written, including report writing and record keeping
* Presentation and influencing skills
* Understanding of the application of research within clinical and research governance
* Facilitation of development of other staff
* Excellent organisation and time management skills with ability to prioritise and meet deadlines
* Good working knowledge of Microsoft Office applications (Teams, Word, PowerPoint, Access, Excel, Publisher)
Desirable criteria
* Demonstrates appreciation of how Trust organisational objectives are underpinned by research
* Evidence of leading complex projects
Personal Qualities/Special Circumstances
Essential criteria
* Ability to work autonomously while coordinating multiple projects
* Supportive and proactive in the development of self and others
* Evidence of continuing professional development
Desirable criteria
* Evidence of initiative to solve complex problems
* Evidence of adaptability and flexibility under pressure
If you have not received a communication within three weeks of the closing date, please assume your application was unsuccessful.
North Bristol NHS Trust does not reimburse travel expenses for interview attendance.
For applicants meeting requirements of the Disability Act / Two Ticks scheme requiring further support, contact 0117 414 1151.
North Bristol NHS Trust is committed to safeguarding and promoting the welfare of children and young people.
Successful applicants will normally commence at the minimum of the scale unless they have previous NHS service at the same band. Progression through the scale is by annual increments.
We encourage applications from under‑represented groups including Black, Asian, minority ethnic backgrounds, disabled people and LGBTQIA+ people.
Stringent pre‑employment checks are undertaken on all successful applicants prior to commencement.
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