Lead Research Nurse - ROSSINI

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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. We are looking for an enthusiastic and motivated individual who is keen to develop their research experience as part of a multi-professional and highly skilled Research and Development department. This is a great opportunity for the successful applicant to be part of the largest surgical trial in the UK and to expand their professional network both within the Trust and nationally.

The post holder will be working across sites to drive and support the recruitment and roll out of the ROSSINI-Platform trial with the responsibility for delivering high quality research and clinical care within an innovative, multi arm multi stage (MAMS) trial.

This post is offered as fixed term to deliver this specific project, though the successful applicant would develop skills and experience that could support application to future opportunities within the department.

R&D at NBT has recently sustained its Silver accreditation with "Investors in People", which exemplifies our commitment to lead, develop and support our staff to be the best they can be!

Main duties of the job
The post holder will:

• Review trial documentation;
• Support trial uptake;
• Support site openings including training and compliance for sites;
• Dissemination of best practice in terms of pathways, recruitment and use of the digital wound hub;
• Help with engagement and participation in the NIHR Associate Principle Investigator (PI) scheme;
• Engagement with trainee-centric research collaboratives including training, obtaining GCP, maintaining site delegation logs;
• Attend and contribute to the running of the trial through attendance and contribution to the pillar Trial Management Group;
• Improve the interface between sites.

Working for our organisation
North 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 specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.

North 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.

Detailed Job Description And Main 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 ISO 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.
• 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 Regional Research Delivery Network (previously Clinical Research Network) throughout the study and facilitate the lines of communication between the Trust / R+D and the NIHR RRDN.
• Have 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.
• Be involved in the financial processes associated with coordinating research studies and grant applications.
• Have the ability and drive to initiate and/or undertake original research.
• Be responsible for project managing all the studies in set up.
• Be expected to identify any blockages to study set up and work with R+D to identify strategies to mitigate them.
• Be expected to establish and update Standard Operating Procedures and support 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.

• 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.

• Act in the best interests of the research subjects to ensure their rights are upheld.

• Ensure Protocol amendments are incorporated into research practice.

• Act as an expert resource for staff in relation to the financial management of clinical research studies.

• Use expert judgement in relation to competing demands for funding/resources.

• Act 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.

• Be 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 Regional Research Delivery 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 Regional Research Delivery Network.

• Work within the range of research guidelines, ethical principles, and protocols, whilst adhering to organisational policies and procedures.

• Always observe the confidentiality of patient information, in accordance with the Data Protection Act and Caldicott regulations.

• Communicate with R&D/NIHR Regional Research Delivery Network lead regarding research subjects, trial progress, workload issues and personal development.

Person specification
Education/Training/Qualifications
Essential criteria

• RGN with current live Registration.
• 2 years experience at a band 6 or higher in Breast Care or Surgical research delivery.
• Broad clinical knowledge (surgical/breast care).

Desirable criteria

• Post Graduate level 7 (or working towards).
• Evidence of leadership development training.

Work Experience
Essential criteria

• Experience of 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 all relevant legislation.
• Experience managing complex budgets.

Knowledge/Skills/Abilities
Essential criteria

• 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 development of other staff.
• Excellent organisation 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 criteria

• Demonstrates an appreciation of how the Trust Organisational Objectives are underpinned by research.
• Understanding of the application of research within clinical and research governance.
• Evidence of leading complex projects.

Personal Qualities/Special Circumstances
Essential criteria

• Demonstrates an 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 using initiative to solve complex problems.
• Evidence of adaptability and flexibility under pressure.

If you apply for this vacancy and have not received a communication from North Bristol NHS Trust within three weeks of the closing date, please assume that on this occasion your application has been unsuccessful.

Please note that North Bristol NHS Trust does not reimburse travel expenses relating to interview attendance.

North Bristol NHS Trust are committed to safeguarding and promoting the welfare of children and young people and expects all staff and volunteers to share this commitment.

The successful applicant(s) 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.

At North Bristol Trust (NBT), we know diverse and inclusive environments lead to happier and healthier teams and improved patient care and outcomes. We are committed to equality of opportunity, to being fair and inclusive, and to being a place where we all belong. We therefore particularly encourage applications from candidates who are currently underrepresented in NBT’s workforce at Band 8a and above. These include people from Black, Asian and minority ethnic backgrounds, disabled people and LGBTQIA+ people.

Please note that stringent pre-employment checks are undertaken on all successful applicants prior to commencement in post.