Job summary
We have an exciting opportunity for a Research Nurses / Clinical Trial Coordinator to come and join the Orthopaedic Research Team at Denmark Hill working in close collaboration with the Department of Haematology. The Department of Haematology in partnership with Celgene / Bristol-Myers Squibb are conducting a multi-site study to investigate how genetic and immunological changes in the blood are associated with disease outcomes. The study will recruit a large cohort of healthy individuals (predominately orthopaedic patients) and patients with myeloid neoplasms in a comparative study of clonal haemopoiesis. The study aims to integrate clinical data and multidisciplinary research outputs to identify new diagnostic tools, targets for therapy, and generate predictive models of disease and response to treatment through bioinformatics analysis.
The post holder will be expected to work towards the successful delivery of the research protocol across multiple sites in the region. The poster holder will support a seamless coordination of the study between research teams, orthopaedic surgeries, tissue collection and timely delivery to laboratories and ensure accurate clinical data is captured at all times. The post is initially for 6-month contract with potential extension 12-month contract.
Main duties of the job
The post holder will be responsible for coordinating the 'CHIP' research study and will be expected to work flexibly to support other clinical trials / research as needed. The post holder will need to be able to work as part of a team and at times autonomously, providing support to the Lead Research Nurse and where appropriate direct and provide support to junior staff.The post holder will be based in the Orthopaedic research department and the day-to-day management will be by the Lead Research Nurse and the Orthopaedic RDU Clinical Research Manager, in close conjunction with the study Programme Manager.
The post holder will be expected to help coordinate and closely monitor the trial protocol, ensuring trial governance and patient safety is prioritised. As a research nurse, the post holder will need to attend clinic, wards and multi-disciplinary meetings to coordinate and manage the trial and where appropriate, help identify patients suitable for entry into trials. The post holder will need to work closely with suitably qualified staff within the trial team and/or wider Orthopaedic and Haematology nursing team to ensure all drug administration (where applicable) and other clinical nursing responsibilities are both in line with the study protocol and 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 Reachis 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 in support / conjunction with the Senior Research Nurse to manage a number of trials, ensuring trial protocols and governance are strictly adhered to, managed within EU clinical trial directives in accordance with ICH GCP (International Conference on Harmonisation and Good Clinical Practice) and ensuring a duty of care to the patient and their families.
- Identify patients suitable for entry into clinical research studies / trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings.
- Be aware of and on occasion (and if trained and on the approval log) participate in the informed consent process
- Support and help coordinate the research patient pathway from screening through to study/trial closure
- Ensure that adequate precautions are taken to minimise the risk of cross-infection in relation to the safe disposal of body fluids including blood products.
- Be aware of and report any side effects as outlined in the protocol, in association with local nursing teams.
- Maintain adequate patients records and ensure all relevant information is documented in the patients medical and nursing notes
- Be responsible for accurate completion of Case Report Forms (CRFs) delegated to them.
- Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
- If appropriately trained, undertake agreed procedures, in line with trial and Trust procedures, to include: venepuncture, temperature, pulse, blood pressure checks, ECGs, height, weight, urinalysis and measuring O2 sats and respiratory rate. If not appropriately training, ensure these procedures are undertaken by suitably trained staff in line with trial and Trust procedures.
- Act as a role model for excellence in orthopaedic and haematology based research.
Portfolio Management and Development
- Review trial protocols and support the Senior Research Nurse to identify resource implications for the site.
- Liaise with the research team, medical team/sponsor organisation to co-ordinate the on-study treatment/assessments and patient follow up.
- Liaise with Clinical Trial Set Up staff to help assist in the set-up of trials.
- Assist in completing submissions to Research & Innovation departments of relevant sites.
- Process amendments and disseminate information to relevant departments
- Ensure that accrual data is reported to the Sponsors/Trust as required.
- To be able to provide information to allow for invoices to be raised for payments where appropriate
- Build strong professional relationships with other departments in order to promote a good working environment.
- Participate in the presentation of research findings within the Trust.
- To report adverse incidents and near misses in line with Trust policy.
- Support the Senior Research Nurse to maintain a dialogue of progress with the Clinical Trials Manager, 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.
Professional Development and Leadership
- The post holder will support the development and implementation of strategies to maintain and increase the level of patient recruitment into orthopaedic / haematology research within KCH and wherever possible help to maintain the high profile of KCH in line with the Trust strategy
- To innovate and contribute to the development of Network wide clinical and research policies and procedures.
- To support the Senior Research Nurse and Clinical Trials Manager in ensuring that the Trust is meeting the accrual targets for both NIHR CRN and commercial trials and to take action to address any shortfalls.
- To implement strategies and systems for quality assurance
- Attend the training programmes and other relevant education and training days as agreed in your development plan.
- Attend investigator meetings and conferences when required
- Takes personal responsibility for own professional growth, keep up to date with professional development and research and to undertake an annual appraisal (internal performance review) to identify personal objectives and development needs
- Prepare posters/research papers for meetings, conferences and publications.
- Represent the research team at local and national forums
- Participate in service development.
- Support other members of the team
- Manage and ensure adherence to trust policies throughout the team
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 times.
This job description does not contain an exhaustive list of duties and you may be required to undertake additional responsibilities. Periodic review will occur in order to adapt and develop the role according to the service needs and hospital policies.
Job description
Job responsibilities
Clinical Responsibilities
- Work in support / conjunction with the Senior Research Nurse to manage a number of trials, ensuring trial protocols and governance are strictly adhered to, managed within EU clinical trial directives in accordance with ICH GCP (International Conference on Harmonisation and Good Clinical Practice) and ensuring a duty of care to the patient and their families.
- Identify patients suitable for entry into clinical research studies / trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings.
- Be aware of and on occasion (and if trained and on the approval log) participate in the informed consent process
- Support and help coordinate the research patient pathway from screening through to study/trial closure
- Ensure that adequate precautions are taken to minimise the risk of cross-infection in relation to the safe disposal of body fluids including blood products.
- Be aware of and report any side effects as outlined in the protocol, in association with local nursing teams.
- Maintain adequate patients records and ensure all relevant information is documented in the patients medical and nursing notes
- Be responsible for accurate completion of Case Report Forms (CRFs) delegated to them.
- Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
- If appropriately trained, undertake agreed procedures, in line with trial and Trust procedures, to include: venepuncture, temperature, pulse, blood pressure checks, ECGs, height, weight, urinalysis and measuring O2 sats and respiratory rate. If not appropriately training, ensure these procedures are undertaken by suitably trained staff in line with trial and Trust procedures.
- Act as a role model for excellence in orthopaedic and haematology based research.
Portfolio Management and Development
- Review trial protocols and support the Senior Research Nurse to identify resource implications for the site.
- Liaise with the research team, medical team/sponsor organisation to co-ordinate the on-study treatment/assessments and patient follow up.
- Liaise with Clinical Trial Set Up staff to help assist in the set-up of trials.
- Assist in completing submissions to Research & Innovation departments of relevant sites.
- Process amendments and disseminate information to relevant departments
- Ensure that accrual data is reported to the Sponsors/Trust as required.
- To be able to provide information to allow for invoices to be raised for payments where appropriate
- Build strong professional relationships with other departments in order to promote a good working environment.
- Participate in the presentation of research findings within the Trust.
- To report adverse incidents and near misses in line with Trust policy.
- Support the Senior Research Nurse to maintain a dialogue of progress with the Clinical Trials Manager, 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.
Professional Development and Leadership
- The post holder will support the development and implementation of strategies to maintain and increase the level of patient recruitment into orthopaedic / haematology research within KCH and wherever possible help to maintain the high profile of KCH in line with the Trust strategy
- To innovate and contribute to the development of Network wide clinical and research policies and procedures.
- To support the Senior Research Nurse and Clinical Trials Manager in ensuring that the Trust is meeting the accrual targets for both NIHR CRN and commercial trials and to take action to address any shortfalls.
- To implement strategies and systems for quality assurance
- Attend the training programmes and other relevant education and training days as agreed in your development plan.
- Attend investigator meetings and conferences when required
- Takes personal responsibility for own professional growth, keep up to date with professional development and research and to undertake an annual appraisal (internal performance review) to identify personal objectives and development needs
- Prepare posters/research papers for meetings, conferences and publications.
- Represent the research team at local and national forums
- Participate in service development.
- Support other members of the team
- Manage and ensure adherence to trust policies throughout the team
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 times.
This job description does not contain an exhaustive list of duties and you may be required to undertake additional responsibilities. Periodic review will occur in order to adapt and develop the role according to the service needs and hospital policies.
Person Specification
Education/Qualifications
Essential
- NMC Level One Registration - RN Adult
- Evidence of continuous personal, professional and academic development
Desirable
- Relevant post registration qualification
- GCP qualification
Previous experience
Essential
- Knowledge and experience of working with different profession groups and handling relationships
- Previous research or clinical trial experience
Desirable
- Previous post-registration experience within the oncology/research/haematology/orthopaedic setting
- Experience in theatre / surgical environment
- Good Venepuncture Skills
- Experience of collaborating with other agencies
Skills/Knowledge/Ability
Essential
- Understanding of Regulatory requirements pertaining to trials
- Excellent communication and interpersonal skills
- Excellent IT skills Evidence of accuracy to detail in data collection
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
Desirable
- Report writing and presentational skills
Physical Requirements
Essential
- Willingness to travel across sites and within the community for patient home visits
- Ability to work flexible hours as required
Person Specification
Education/Qualifications
Essential
- NMC Level One Registration - RN Adult
- Evidence of continuous personal, professional and academic development
Desirable
- Relevant post registration qualification
- GCP qualification
Previous experience
Essential
- Knowledge and experience of working with different profession groups and handling relationships
- Previous research or clinical trial experience
Desirable
- Previous post-registration experience within the oncology/research/haematology/orthopaedic setting
- Experience in theatre / surgical environment
- Good Venepuncture Skills
- Experience of collaborating with other agencies
Skills/Knowledge/Ability
Essential
- Understanding of Regulatory requirements pertaining to trials
- Excellent communication and interpersonal skills
- Excellent IT skills Evidence of accuracy to detail in data collection
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
Desirable
- Report writing and presentational skills
Physical Requirements
Essential
- Willingness to travel across sites and within the community for patient home visits
- Ability to work flexible hours as required
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).
