Job summary
We are seeking an enthusiastic individual to join our dynamic team in the Musculoskeletal Research Unit within the Translational Health Sciences department of Bristol Medical School based at Southmead Hospital.
This is a unique opportunity to develop in one of the largest orthopaedic health services research groups in the UK.
The post holder will join an established multi-disciplinary team of academic and clinical staff that conducts a varied programme of research into improving patient's experiences and outcomes of orthopaedic surgery.
As a senior research nurse, AHP or CRP, you will be responsible for leading nationwide delivery of NIHR funded multi-centre trials, focusing on knee and hip replacements, working closely with external delivery teams and leading the local delivery team.
You will be part of programme of research which will include the world's largest randomised trial of hip implants, the results of which have the potential to change orthopaedic practice worldwide.
The post is advertised as full time but we will consider part time or job share for the right candidate.
We have recently been awarded Silver accreditation with "Investors in People" which underlines our commitment to support and lead our staff to be the best they can be.
If you would like to learn more about the role please do get in touch.
Main duties of the job
The successful applicant will work as part of an established multidisciplinary team of clinical and academic staff to deliver a portfolio of high quality research funded by NIHR. They will:
- Lead the local research delivery team, provide line management, support training and development.
- Work closely with external trial delivery teams across the UK to ensure trials are delivered to high research and governance standards.
- Co-ordinate the setup up, running and close out of research projects, ensuring delivery local and nationally to agreed targets and milestones.
- Work with the University of Bristol teams on development of protocols, patient documentation and standard operating procedures; contribute to site initiation visits and provide expertise and guidance on research studies as required.
- Manage resources within the department, including staff, resources, finance and risk management.
Applications are open to enthusiastic researchers committed to improving the health and well-being of people living with musculoskeletal conditions through high quality research. Academic training and development will be available for the right applicant.
About us
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.
Job description
Job responsibilities
Please see Full JD for more descriptions.
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 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.
- 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 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.
- 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 Regional Research Delivery Network lead regarding research subjects, trial progress, workload issues and personal development.
Job description
Job responsibilities
Please see Full JD for more descriptions.
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 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.
- 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 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.
- 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 Regional Research Delivery 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
- Broad clinical knowledge
Desirable
- Recent clinical research delivery experience
Work Experience
Essential
- 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 to ensure compliance with all 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 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
- Some Research knowledge including ICH-GCP inc. UK Statutory Instruments
- Demonstrates an appreciation of how the Trust Organisational Objectives are underpinned by research
- Understanding of the application of research within clinical and research governance
Personal Qualities/Special Circumstances
Essential
- Demonstrates an ability to work autonomously while coordinating multiple projects
- Supportive and proactive in the development of self and others
Desirable
- Evidence of continuing professional 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
- Broad clinical knowledge
Desirable
- Recent clinical research delivery experience
Work Experience
Essential
- 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 to ensure compliance with all 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 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
- Some Research knowledge including ICH-GCP inc. UK Statutory Instruments
- Demonstrates an appreciation of how the Trust Organisational Objectives are underpinned by research
- Understanding of the application of research within clinical and research governance
Personal Qualities/Special Circumstances
Essential
- Demonstrates an ability to work autonomously while coordinating multiple projects
- Supportive and proactive in the development of self and others
Desirable
- Evidence of continuing professional development
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).
Employer details
Employer name
North Bristol NHS Trust
Address
Southmead Hospital
Research & Development, Clinical Research Centre, Southmead Hospital, Bristol, BS10 5NB
Bristol
BS10 5NB
Employer's website
https://www.nbt.nhs.uk (Opens in a new tab)
