Job summary
We have an exciting opportunity for a Senior Research Nurse join our busy, dynamic team in the Liver Research Unit at Denmark Hill.
The post holder will be expected to lead the coordination and successful delivery of clinical trials, carry out feasibility reviews for new studies and contribute to trial costing and trial budgetary management. The post holder will be tasked with line management and leadership responsibilities and will be expected to actively involve themselves in the development and growth of the unit, supporting senior members of staff where required.
Successful candidates will need to have substantial experience within liver research, be confident and knowledgeable of handling complex trials and be committed to delivering a high standard of care within a challenging, dynamic clinical environment. Key skills include excellent communication and coordination skills, attention to detail, regulatory knowledge and the ability to lead a team to reach a given goal.
Main duties of the job
The post holder will have responsibility for leading a portfolio of clinical trials and managing junior staff, including Clinical Trial and Data coordinators. The post holder will need to be able to work autonomously, providing both management and leadership to junior staff, closely monitoring and coordinating the trial protocol and ensuring trial governance and patient safety are prioritised. The post holder will be expected to lead the coordination of phase I to III clinical trials, carry out feasibility reviews for new studies and contribute to trial costing and trial management.
As a Trial Lead the post holder will need to attend clinic, wards and multi-disciplinary meetings to identify patients suitable for entry into trials and ensure the informed consent process is strictly followed.
The post holder will take overall responsibility for the administration of trial drugs and must be aware of and ensure any side effects are reported in line with the protocol, good clinical practice, trust procedures and guidelines.
About us
King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c£1 billion, 1.5 million patient contacts a year and around 14,000 staff based across 5 main sites in South East London. The Trust provides a full range of local hospital services across its different sites, and specialist services from King's College Hospital (KCH) sites at Denmark Hill in Camberwell and at the Princess Royal University Hospital (PRUH) site in Bromley.
King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.
The trust-wide strategy Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we can take Team King's to another level.
Job description
Job responsibilities
Clinical Responsibilities
- Work autonomously to manage a large portfolio of studies, ensuring trial protocols and governance are strictly adhered to and ensuring a duty of care to the patient and their families.
- Responsible for managing and leading phase I to III studies and contributing to the trial costing and budgetary management.
- Ensure trials are managed within EU clinical trial directives in accordance with ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times.
- Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings and liaising with disease specific Clinical Nurse Specialists.
- Participate in the informed consent process acting as a resource and support to patients and their families
- Responsible for coordinating the research patient pathway from screening through to trial closure
- Responsible for overseeing / supporting the administration of trial drugs (commensurate with education and training), being aware of and / or ensuring the reporting of any side effects as outlined in the protocol and or Trust guidelines, in association with local nursing teams and medical staff.
- Responsible for the maintenance of adequate patient records and ensuring all relevant information is documented in the patients medical and nursing notes.
- Responsible for accurate, timely and regular completion of Clinical Report Forms (CRFs).
- Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
- Identify strategies for recruiting patients to clinical trials and support less experienced team members to implement those strategies
- Act as a role model for excellence in Liver research.
Portfolio Management and Development
- Responsible for reviewing trial protocols and identifying resource implications for the site.
- Liaise with the medical team/sponsor organisation and be responsible for co-ordinating the on-study treatment and follow up of patient.
- Supervise the research team to ensure the robust collation of data generated from clinical trials.
- Responsible for ensuring accrual data is reported to the Sponsors as required and that relevant information is recorded and made available to allow invoices to be raised for payments where / when appropriate.
- Build strong professional relationships with other departments in order to promote a good working environment.
- Educate appropriate medical and nursing personnel and departments of portfolio of clinical trials.
- Participate in the presentation of research findings within the Trust.
- Report adverse incidents and near misses in line with Trust policy.
- Maintain a dialogue of progress with the Research Matron, Lead Trial consultant and Lead investigator.
- Attend monthly portfolio performance review meetings: identify and act on issues.
- Provide cover when necessary for annual leave, study leave, sick leave
- Contribute to yearly business planning to ensure the research team is properly structured and resourced at all times.
Staff Management and Leadership
- Management responsibility for a group of staff including nursing, lab, trial coordinators and administrative staff.
- Provide leadership and support to staff within designated areas ensuring that they are managed in line with Trust policies.
- Assist the Research Matron in the recruitment and selection, of junior staff including nursing, lab, data managers, admin staff and clinical trial coordinators and to be responsible for their induction, training and personal development.
- Conduct staff appraisals, set objectives and review performance of staff using agreed KSF outlines identifying individual training and development needs and promote continuing personal and professional development.
- Manage sickness, disciplinary and performance issues in line with Trust policies.
- Ensure compliance with all relevant Trust policies and standing financial instructions.
- Assess resource availability and take timely action to minimise the impact of any staff shortage on service delivery.
- Ensure that all staff are informed of the Trial Unit and where appropriate Divisions objectives and performance targets and are aware of the importance of their contribution to delivery them.
Personal and Professional Development
- The post holder will take a lead in service development for the research team, directorate and the Trust.
- Develop and implement the key worker concept within the Research Team.
- Develop and implement strategies to maintain and increase the level of patient recruitment into liver clinical trials within KCH.
- Maintain the high profile of KCH in line with the liver research strategy
- Innovate and contribute to the development of Network wide clinical and research policies and procedures.
- Work with the Research Matron in ensuring that the Trust is meeting the accrual targets for both CRN and commercial trials and to take action to address any shortfalls.
- Responsible for implementing and where appropriate developing strategies and systems for quality assurance
- Attend the training programmes and other relevant education and training days as agreed within the post holders personal development plan.
- Attend investigator meetings and conferences when required.
- Take personal responsibility for own professional growth and keep up to date with professional development and research.
- Prepare posters/research papers for meetings, conferences and publications.
- Represent the research team at local and national forums.
- Mentor and support other members of the team.
- Participate in clinical supervision as both supervisor and supervisee in accordance with the NMC guidelines.
- Undertake performance review at regular intervals and an annual appraisal to identify personal objectives and development needs.
- Manage and ensure adherence to trust policies throughout the team.
- If the post holder has a nursing qualification they will need to ensure continued effective registration with the NMC and be aware of NMC Code of Professional Conduct. Be accountable for their own practice. To work within the NMC Scope of Professional Practice and ensure competency to undertake duties as allocated.
GENERAL
- The post holder has a general duty of care for their own health, safety and well being and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.
- To observe the rules, policies, procedures and standards of King's College Hospital NHS Foundation Trust together with all relevant statutory and professional obligations.
- To observe and maintain strict confidentiality of personal information relating to patients and staff.
- To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues.
- This job description is intended as a guide to the general scope of duties and is not intended to be definitive or restrictive. It is expected that some of the duties will change over time and this description will be subject to review in consultation with the post holder.
- The post holder has an important responsibility for and contribution to infection control and must be familiar with the infection control and hygiene requirements of this role.
- These requirements are set out in the National Code of Practice on Infection Control and in local policies and procedures which will be made clear during your induction and subsequent refresher training. These standards must be strictly complied with at all.
Job description
Job responsibilities
Clinical Responsibilities
- Work autonomously to manage a large portfolio of studies, ensuring trial protocols and governance are strictly adhered to and ensuring a duty of care to the patient and their families.
- Responsible for managing and leading phase I to III studies and contributing to the trial costing and budgetary management.
- Ensure trials are managed within EU clinical trial directives in accordance with ICH GCP (International Conference on Harmonisation and Good Clinical Practice) ensuring that the clinical trial protocol is adhered to at all times.
- Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings and liaising with disease specific Clinical Nurse Specialists.
- Participate in the informed consent process acting as a resource and support to patients and their families
- Responsible for coordinating the research patient pathway from screening through to trial closure
- Responsible for overseeing / supporting the administration of trial drugs (commensurate with education and training), being aware of and / or ensuring the reporting of any side effects as outlined in the protocol and or Trust guidelines, in association with local nursing teams and medical staff.
- Responsible for the maintenance of adequate patient records and ensuring all relevant information is documented in the patients medical and nursing notes.
- Responsible for accurate, timely and regular completion of Clinical Report Forms (CRFs).
- Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
- Identify strategies for recruiting patients to clinical trials and support less experienced team members to implement those strategies
- Act as a role model for excellence in Liver research.
Portfolio Management and Development
- Responsible for reviewing trial protocols and identifying resource implications for the site.
- Liaise with the medical team/sponsor organisation and be responsible for co-ordinating the on-study treatment and follow up of patient.
- Supervise the research team to ensure the robust collation of data generated from clinical trials.
- Responsible for ensuring accrual data is reported to the Sponsors as required and that relevant information is recorded and made available to allow invoices to be raised for payments where / when appropriate.
- Build strong professional relationships with other departments in order to promote a good working environment.
- Educate appropriate medical and nursing personnel and departments of portfolio of clinical trials.
- Participate in the presentation of research findings within the Trust.
- Report adverse incidents and near misses in line with Trust policy.
- Maintain a dialogue of progress with the Research Matron, Lead Trial consultant and Lead investigator.
- Attend monthly portfolio performance review meetings: identify and act on issues.
- Provide cover when necessary for annual leave, study leave, sick leave
- Contribute to yearly business planning to ensure the research team is properly structured and resourced at all times.
Staff Management and Leadership
- Management responsibility for a group of staff including nursing, lab, trial coordinators and administrative staff.
- Provide leadership and support to staff within designated areas ensuring that they are managed in line with Trust policies.
- Assist the Research Matron in the recruitment and selection, of junior staff including nursing, lab, data managers, admin staff and clinical trial coordinators and to be responsible for their induction, training and personal development.
- Conduct staff appraisals, set objectives and review performance of staff using agreed KSF outlines identifying individual training and development needs and promote continuing personal and professional development.
- Manage sickness, disciplinary and performance issues in line with Trust policies.
- Ensure compliance with all relevant Trust policies and standing financial instructions.
- Assess resource availability and take timely action to minimise the impact of any staff shortage on service delivery.
- Ensure that all staff are informed of the Trial Unit and where appropriate Divisions objectives and performance targets and are aware of the importance of their contribution to delivery them.
Personal and Professional Development
- The post holder will take a lead in service development for the research team, directorate and the Trust.
- Develop and implement the key worker concept within the Research Team.
- Develop and implement strategies to maintain and increase the level of patient recruitment into liver clinical trials within KCH.
- Maintain the high profile of KCH in line with the liver research strategy
- Innovate and contribute to the development of Network wide clinical and research policies and procedures.
- Work with the Research Matron in ensuring that the Trust is meeting the accrual targets for both CRN and commercial trials and to take action to address any shortfalls.
- Responsible for implementing and where appropriate developing strategies and systems for quality assurance
- Attend the training programmes and other relevant education and training days as agreed within the post holders personal development plan.
- Attend investigator meetings and conferences when required.
- Take personal responsibility for own professional growth and keep up to date with professional development and research.
- Prepare posters/research papers for meetings, conferences and publications.
- Represent the research team at local and national forums.
- Mentor and support other members of the team.
- Participate in clinical supervision as both supervisor and supervisee in accordance with the NMC guidelines.
- Undertake performance review at regular intervals and an annual appraisal to identify personal objectives and development needs.
- Manage and ensure adherence to trust policies throughout the team.
- If the post holder has a nursing qualification they will need to ensure continued effective registration with the NMC and be aware of NMC Code of Professional Conduct. Be accountable for their own practice. To work within the NMC Scope of Professional Practice and ensure competency to undertake duties as allocated.
GENERAL
- The post holder has a general duty of care for their own health, safety and well being and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.
- To observe the rules, policies, procedures and standards of King's College Hospital NHS Foundation Trust together with all relevant statutory and professional obligations.
- To observe and maintain strict confidentiality of personal information relating to patients and staff.
- To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues.
- This job description is intended as a guide to the general scope of duties and is not intended to be definitive or restrictive. It is expected that some of the duties will change over time and this description will be subject to review in consultation with the post holder.
- The post holder has an important responsibility for and contribution to infection control and must be familiar with the infection control and hygiene requirements of this role.
- These requirements are set out in the National Code of Practice on Infection Control and in local policies and procedures which will be made clear during your induction and subsequent refresher training. These standards must be strictly complied with at all.
Person Specification
Qualifications
Essential
- NMC Registered Nurse Level 1
- ICH/GCP Training
Desirable
- Post-graduate qualification with a research methodology element
Experience
Essential
- Line Management experience
- Previous experience of conducting clinical trials in phases 1-3
- Substantial experience within the research / liver setting
Desirable
- Experience of audit and quality management systems
Skills and Ability
Essential
- Understanding of Regulatory requirements pertaining to trials
- Excellent communication and interpersonal skills
- Evidence of working as an independent practitioner within a multi-disciplinary team
Person Specification
Qualifications
Essential
- NMC Registered Nurse Level 1
- ICH/GCP Training
Desirable
- Post-graduate qualification with a research methodology element
Experience
Essential
- Line Management experience
- Previous experience of conducting clinical trials in phases 1-3
- Substantial experience within the research / liver setting
Desirable
- Experience of audit and quality management systems
Skills and Ability
Essential
- Understanding of Regulatory requirements pertaining to trials
- Excellent communication and interpersonal skills
- Evidence of working as an independent practitioner within a multi-disciplinary 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).
Employer details
Employer name
King's College Hospital NHS Foundation Trust
Address
King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
Employer's website
https://www.kch.nhs.uk/ (Opens in a new tab)
