Job summary
We are looking for an enthusiastic and motivated clinical research nurse who can deliver excellent patient care and is able to use their leadership and engagement skills to contribute to the growing research portfolio and research staff within the Royal National Orthopaedic Hospital.
Therefore it is essential you are already working as a clinical research nurse either in the NHS or other institutions (e.g. academic research or industry).
This is a full-time role (37.5 hours) mainly based at the Research Innovation Centre at the Stanmore site, however occasional travel may be necessary to Bolsover Street site.
Main duties of the job
As we specialise in orthopaedics, musculoskeletal and spinal injury research your day to day role and portfolio may vary, however the main responsibilities are:
- Line management, leadership and training of research nurses
- Involved in all aspects of your studies from set-up to close-down
- Working closely with senior Clinical Research Practitioner and Delivery Manager
- Working independently but also teamwork within the research delivery team and governance team
- Training the wider clinical team and research engagement
About us
Rated Good by the CQC
- Two sites, one in central London and one in Stanmore - which has recently opened The Stanmore Building, a new, state-of-the-art inpatient facility
- Our Research and Innovation Centre works closely with our main academic partner, University College London
- Recognised as a centre of excellence, leading on national initiatives, such as theGetting It Right First Time (GIRFT)Programme
- Further major redevelopment underway across the Stanmore site - improving and modernising our facilities to maintain our position as the UK's leading centre for orthopaedic medicine
- In the NHS staff survey, over 90% of our staff were satisfied with the quality of care they are able to give to patients - the best result of any NHS Trust in the country
- Our staff also indicated that they had the best experience of appraisals as compared to all other NHS Trusts.
This is a great time to join us and play a critical role in the next stage of RNOH's journey to achieving an outstanding CQC rating.
We are committed to equal opportunities in employment and offer a range of flexible working practices. Part-time and job share applications will be considered.
We reserve the right to close this advert early due to the volume of applicants. Please apply as soon as possible to avoid disappointment.
Job description
Job responsibilities
Main Duties and Responsibilities
Clinical Research
- Work independently and autonomously to manage complex trial portfolio and able to delegate where appropriate
- Screening and recruiting eligible patients to research studies
- Working closely with senior clinical research practitioner and delivery team manager to ensure structure and organisation for the delivery team
- Assist the PIs to identify patients to take part in research studies, ensuring adherence to the protocol
- Liaise with all relevant clinical staff where research is being conducted
- Be directly involved in feasibility and regulatory approval submissions for some projects where such support is required
- Ensure participants are recruited to study timelines, and, report any concerns to Research Delivery Manager
- Ensure accurate data is collected and entered according to sponsor timelines
- Report any anomalies in data to the relevant Trial Manager and / or lead Investigator, and R&D Department
- Report any protocol deviations to the relevant Trial Manager and / or Investigator and Research Delivery Manager
- Report any protocol violations to relevant Trial Manager and / or lead Investigator, Research Delivery Manager and R&D Department
- Arrange and support study monitoring visits and audits when required
- Have understanding of research methodologies in order to apply those to process
- Have knowledge and understanding of UK systems in relation to regulatory bodies (e.g. REC, MHRA), as well as understanding of NHS support costs funding environments and clinical research network structures
- Ensure compliance with GCP and required regulations
- Ensure that relevant SOPs are implemented, and contribute to development of new SOPs when required
- Ensure that departmental working practice documents (WPDs) are followed and implemented and contribute to the development of new WPDs
- Ensure that studies recruitment and finance logs are kept up to date
- Establish communication with relevant MDTs and clinical teams to support research
- Establish and maintain good channels of communication with other departments within the Trust as well as externally (e.g. liaising with Sponsors, CRAs and academic institutions regarding study set-up and progress)
- Establish good trial documentation management systems, and tracking for recruitment
- Support & deputise for Research Delivery Manager as and when required
- Any other relevant duties as and when required
- Support established engagement initiatives (e.g. research nurse champions, student nurse placements) and help to develop further engagement initiatives where needed
Management and Leadership
- Line management duties for clinical research nurses, involving probation meetings, appraisals and mentorship
- Support all research staff when necessary, including research nurses, practitioners, apprentices and data managers
- Act as a role model for other members of the team
- Engage in delivery of any changes
- Ensure that departmental as well as Trust policies are adhered to
- Assist with induction and training of new staff
Clinical
- Use nursing skills and knowledge to uphold patient safety in clinical trials
- Source and undertake further training for advanced clinical skills and create training and development opportunities for clinical research nurses
- Co-operate with medical and research staff in dealing with patient care problems associated with research
- Identify research training needs of clinical research nurses and ensure adhering to research competencies
- Ensure clinical research nurses are working to the NMC code of conduct and up to date with nursing related practices e.g. re-validation
Other
- Have knowledge of the:
- Patient Charter
- Health and Safety at Work Policy
- Equal Opportunities Policy
- Complaints Policy
- Disciplinary Policy and Grievance Procedure / Policy regarding Radiation Hazards
Job description
Job responsibilities
Main Duties and Responsibilities
Clinical Research
- Work independently and autonomously to manage complex trial portfolio and able to delegate where appropriate
- Screening and recruiting eligible patients to research studies
- Working closely with senior clinical research practitioner and delivery team manager to ensure structure and organisation for the delivery team
- Assist the PIs to identify patients to take part in research studies, ensuring adherence to the protocol
- Liaise with all relevant clinical staff where research is being conducted
- Be directly involved in feasibility and regulatory approval submissions for some projects where such support is required
- Ensure participants are recruited to study timelines, and, report any concerns to Research Delivery Manager
- Ensure accurate data is collected and entered according to sponsor timelines
- Report any anomalies in data to the relevant Trial Manager and / or lead Investigator, and R&D Department
- Report any protocol deviations to the relevant Trial Manager and / or Investigator and Research Delivery Manager
- Report any protocol violations to relevant Trial Manager and / or lead Investigator, Research Delivery Manager and R&D Department
- Arrange and support study monitoring visits and audits when required
- Have understanding of research methodologies in order to apply those to process
- Have knowledge and understanding of UK systems in relation to regulatory bodies (e.g. REC, MHRA), as well as understanding of NHS support costs funding environments and clinical research network structures
- Ensure compliance with GCP and required regulations
- Ensure that relevant SOPs are implemented, and contribute to development of new SOPs when required
- Ensure that departmental working practice documents (WPDs) are followed and implemented and contribute to the development of new WPDs
- Ensure that studies recruitment and finance logs are kept up to date
- Establish communication with relevant MDTs and clinical teams to support research
- Establish and maintain good channels of communication with other departments within the Trust as well as externally (e.g. liaising with Sponsors, CRAs and academic institutions regarding study set-up and progress)
- Establish good trial documentation management systems, and tracking for recruitment
- Support & deputise for Research Delivery Manager as and when required
- Any other relevant duties as and when required
- Support established engagement initiatives (e.g. research nurse champions, student nurse placements) and help to develop further engagement initiatives where needed
Management and Leadership
- Line management duties for clinical research nurses, involving probation meetings, appraisals and mentorship
- Support all research staff when necessary, including research nurses, practitioners, apprentices and data managers
- Act as a role model for other members of the team
- Engage in delivery of any changes
- Ensure that departmental as well as Trust policies are adhered to
- Assist with induction and training of new staff
Clinical
- Use nursing skills and knowledge to uphold patient safety in clinical trials
- Source and undertake further training for advanced clinical skills and create training and development opportunities for clinical research nurses
- Co-operate with medical and research staff in dealing with patient care problems associated with research
- Identify research training needs of clinical research nurses and ensure adhering to research competencies
- Ensure clinical research nurses are working to the NMC code of conduct and up to date with nursing related practices e.g. re-validation
Other
- Have knowledge of the:
- Patient Charter
- Health and Safety at Work Policy
- Equal Opportunities Policy
- Complaints Policy
- Disciplinary Policy and Grievance Procedure / Policy regarding Radiation Hazards
Person Specification
Knowledge, Training & Experience
Essential
- NMC Registered Nurse
- GCP Certification
- Knowledge of ICH GCP, EU Clinical Trials Directive, Medicines for Human use Regulations and the Research Governance Framework
- Considerable experience in clinical research setting at least at Band 6 or equivalent (e.g. industry or academic research setting)
- Clinically competent to work alone and ensure patient safety
- Venepuncture and cannulation skills
Desirable
- MSc/PGDip other than nursing, relevant to healthcare or clinical research
- Orthopaedics module or certified orthopaedics qualification
- Obtained or willing to undertake modules for further clinical development, as appropriate e.g. from the ACP pathway
IT skills
Essential
- Knowledge and use of different electronic case report forms (eCRFs)
- Able to use Microsoft Software (e.g. Word, Excel, PowerPoint)
Analytical & Judgment Skills
Essential
- Experience in leadership and supervision/mentorship
Desirable
- Line management experience
Communication & Relationship Skills
Essential
- Excellent communication skills
- Able to work in a team
Person Specification
Knowledge, Training & Experience
Essential
- NMC Registered Nurse
- GCP Certification
- Knowledge of ICH GCP, EU Clinical Trials Directive, Medicines for Human use Regulations and the Research Governance Framework
- Considerable experience in clinical research setting at least at Band 6 or equivalent (e.g. industry or academic research setting)
- Clinically competent to work alone and ensure patient safety
- Venepuncture and cannulation skills
Desirable
- MSc/PGDip other than nursing, relevant to healthcare or clinical research
- Orthopaedics module or certified orthopaedics qualification
- Obtained or willing to undertake modules for further clinical development, as appropriate e.g. from the ACP pathway
IT skills
Essential
- Knowledge and use of different electronic case report forms (eCRFs)
- Able to use Microsoft Software (e.g. Word, Excel, PowerPoint)
Analytical & Judgment Skills
Essential
- Experience in leadership and supervision/mentorship
Desirable
- Line management experience
Communication & Relationship Skills
Essential
- Excellent communication skills
- Able to work in a team
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).