Job summary
The post holder will be responsible for co-ordinating an agreed portfolio of non-commercial and commercial clinical trials.
Main duties of the job
Responsibilities will include setting up clinical trials; identifying patients through MDT's/screening notes and increasing referrals through the data base; collecting data; interviewing; supporting and monitoring patients and data entry.
This patient population requires input from a compassionate and caring research professional, with experience caring for and managing patients with cancer; including working with the wider MDT to co-ordinate patient care.
For multi-centre trials led at KCH, the post holder will also be expected to support investigators and their teams at recruiting sites.The post holder will work closely with the Liver Research Manager, Senior Research Nurse/Clinical Trials Coordinator, medical staff, the Clinical Nurse Specialist Teams, the transplant co-ordinators, radiologists and the pharmacy technicians.
About us
The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of 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 aim to take Team King's to another level.
We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.
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.
Job description
Job responsibilities
Clinical Responsibilities
- Work in conjunction with the Senior Research Nurse/Clinical Trials Coordinator to manage a caseload of patients, whilst working as part of a multidisciplinary team.
- Maintain effective communication with patients, carers and professionals to ensure service delivery. Assist in screening patients suitable for entry into clinical trials. This will include attending clinics and Multidisciplinary Team (MDT) meetings.
- Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings.
- With other members of the healthcare team, ensure patients are fully informed prior to entry in anyclinical trial programme.
- Assist in consenting, randomising, allocating of treatment of patients.
- Evaluate patient eligibility for clinical trial entry, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to trial protocol.
- Act as a resource and support to patients and their relatives, explaining practical aspects of clinicaltrials, assisting and supporting local nursing teams.
- Act as key worker for patients while they are on the clinical trial, liaising closely with the clinical nursespecialists to ensure appropriate care and advice provided.
- Coordinate the collection of any blood samples required as part of the clinical trials and ensure safe and appropriate storage of specimens, in conjunction with local nursing teams.
- Ensure the safe packaging and transport of biological specimens as per IATA regulations.
- Support the administration of trial drugs (commensurate with education and training), be aware of andreport any unusual side effects, in association with local nursing teams.
- Maintain adequate patients records and ensure all relevant information is documented in the patientsmedical and nursing notes.
- Responsible for accurate completion of Case Report Forms (CRFs).
- Responsible for the collection, co-ordination and computerisation of data generated from the clinicaltrials.
- Provide continuity of care for patients and their carers throughout the trial programme. Provide specific advice and support as appropriate.
- Ensure patients community care team are fully aware of patients performance / progress while on the study so fully coordinated care is provided.
- Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical TrialsRegulations.
- If appropriately trained, keep up to date with current practices for cannulation, phlebotomy and careof patients with Central Venous Access lines.
- Act as a resource for liver based research.
Portfolio Management and Development
- Assist in the review of trial protocols and identify resource implications for the site.
- Set up and maintain the TMF/ISF with essential documents.
- Help organise initiation meetings.
- Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up ofpatient
- Ensure CRFs are completed accurately and in a timely manner.
- Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsors SOP.
- For network trials, ensure that accrual data is uploaded onto the NIHR CRN portal using the EDGE clinical trials database. Collect and provide information to allow for invoices to be raised for paymentswhere appropriate .
- Liaise with other departments and wards at the site/s, in order to promote a good working environment, integration of research within and open channels of communication.
- Inform appropriate medical personnel and departments of portfolio of clinical trials.
- Participate in the presentation of research findings within the Clinical Research Network South London and outside agencies as appropriate.
- Report adverse incidents and near misses via the Trusts online incident reporting form.
- Coordinate multi-centre trials (where appropriate). Together with the Kings Health Partners ClinicalTrials Office (KHP CTO):
- Ensure all relevant documents and approvals are in place at each site prior to subjectrecruitment.
- Liaise with participating sites, identifying key staff and updating them on trial processes/changes to the protocol and ensuring centres are able to comply with the study protocol.
- Help conduct initiation meetings (if required)
- Collect data from sites, raise data queries and ensure data queries are resolved.
Training and Development
- Attend the KHP CTO, NIHR CRN and CRN South London training programmes and other relevant education and training days/programmes as appropriate.
- Attend investigator/initiation meetings and conferences when required.
- Maintain awareness of current advances in hepatology treatments, research and nursing practice and use this knowledge to maintain high standards of care for Nurse trial patients.
- Disseminate research by assisting in the preparation of posters/research papers for meetings, conferences and publications. Also circulate trial information and carry our presentations locally.
Professional
- Act in accordance with local policies and procedures laid down by Kings College Hospital Institute of Liver Studies.
- Be responsible for maintaining a professional profile.
- Work within the NMC Scope of Professional Practice, Conduct and Record Keeping.
- Undertake an annual appraisal (internal performance review) to identify organisation and professional objectives and development needs.
General
- The post holder has a general duty of care for their own health, safety and wellbeing and that of workcolleagues, visitors and patients within the hospital, in addition to any specific risk management orclinical governance accountabilities associated with this post.
- To observe the rules, policies, procedures and standards of King's College Hospital NHS Trusttogether with all relevant statutory and professional obligations.
- To live and role model the Kings Values of: -Understanding you-Inspiring confidence in our care-Working together-Always aiming higher-Making a difference in our community
- 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 bedefinitive or restrictive. It is expected that some of the duties will change over time and this descriptionwill be subject to review in consultation with the post holder.
- All employees must hold an 'nhs.net' email account which will be the Trust's formal route for emailcommunication.
Safeguarding
The Trust takes the issues of Safeguarding Children, Adults and addressing Domestic Abuse very seriously.All employees have a responsibility to support the organisation in our duties by;-attending mandatory training on safeguarding children and adults- familiarising themselves with the Trust's processes for reporting concerns -reporting any safeguarding child or adult concerns appropriately
Infection control statement
The post holder has an important responsibility for and contribution to infection control and must be familiarwith the infection control and hygiene procedures and requirements when in clinical areas.The post holder has an important responsibility for and contribution to make to infection control and must befamiliar 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 andprocedures, which will be made clear during your induction and subsequent refresher training. Thesestandards must be strictly complied with at all times.
Job description
Job responsibilities
Clinical Responsibilities
- Work in conjunction with the Senior Research Nurse/Clinical Trials Coordinator to manage a caseload of patients, whilst working as part of a multidisciplinary team.
- Maintain effective communication with patients, carers and professionals to ensure service delivery. Assist in screening patients suitable for entry into clinical trials. This will include attending clinics and Multidisciplinary Team (MDT) meetings.
- Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings.
- With other members of the healthcare team, ensure patients are fully informed prior to entry in anyclinical trial programme.
- Assist in consenting, randomising, allocating of treatment of patients.
- Evaluate patient eligibility for clinical trial entry, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to trial protocol.
- Act as a resource and support to patients and their relatives, explaining practical aspects of clinicaltrials, assisting and supporting local nursing teams.
- Act as key worker for patients while they are on the clinical trial, liaising closely with the clinical nursespecialists to ensure appropriate care and advice provided.
- Coordinate the collection of any blood samples required as part of the clinical trials and ensure safe and appropriate storage of specimens, in conjunction with local nursing teams.
- Ensure the safe packaging and transport of biological specimens as per IATA regulations.
- Support the administration of trial drugs (commensurate with education and training), be aware of andreport any unusual side effects, in association with local nursing teams.
- Maintain adequate patients records and ensure all relevant information is documented in the patientsmedical and nursing notes.
- Responsible for accurate completion of Case Report Forms (CRFs).
- Responsible for the collection, co-ordination and computerisation of data generated from the clinicaltrials.
- Provide continuity of care for patients and their carers throughout the trial programme. Provide specific advice and support as appropriate.
- Ensure patients community care team are fully aware of patients performance / progress while on the study so fully coordinated care is provided.
- Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical TrialsRegulations.
- If appropriately trained, keep up to date with current practices for cannulation, phlebotomy and careof patients with Central Venous Access lines.
- Act as a resource for liver based research.
Portfolio Management and Development
- Assist in the review of trial protocols and identify resource implications for the site.
- Set up and maintain the TMF/ISF with essential documents.
- Help organise initiation meetings.
- Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up ofpatient
- Ensure CRFs are completed accurately and in a timely manner.
- Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsors SOP.
- For network trials, ensure that accrual data is uploaded onto the NIHR CRN portal using the EDGE clinical trials database. Collect and provide information to allow for invoices to be raised for paymentswhere appropriate .
- Liaise with other departments and wards at the site/s, in order to promote a good working environment, integration of research within and open channels of communication.
- Inform appropriate medical personnel and departments of portfolio of clinical trials.
- Participate in the presentation of research findings within the Clinical Research Network South London and outside agencies as appropriate.
- Report adverse incidents and near misses via the Trusts online incident reporting form.
- Coordinate multi-centre trials (where appropriate). Together with the Kings Health Partners ClinicalTrials Office (KHP CTO):
- Ensure all relevant documents and approvals are in place at each site prior to subjectrecruitment.
- Liaise with participating sites, identifying key staff and updating them on trial processes/changes to the protocol and ensuring centres are able to comply with the study protocol.
- Help conduct initiation meetings (if required)
- Collect data from sites, raise data queries and ensure data queries are resolved.
Training and Development
- Attend the KHP CTO, NIHR CRN and CRN South London training programmes and other relevant education and training days/programmes as appropriate.
- Attend investigator/initiation meetings and conferences when required.
- Maintain awareness of current advances in hepatology treatments, research and nursing practice and use this knowledge to maintain high standards of care for Nurse trial patients.
- Disseminate research by assisting in the preparation of posters/research papers for meetings, conferences and publications. Also circulate trial information and carry our presentations locally.
Professional
- Act in accordance with local policies and procedures laid down by Kings College Hospital Institute of Liver Studies.
- Be responsible for maintaining a professional profile.
- Work within the NMC Scope of Professional Practice, Conduct and Record Keeping.
- Undertake an annual appraisal (internal performance review) to identify organisation and professional objectives and development needs.
General
- The post holder has a general duty of care for their own health, safety and wellbeing and that of workcolleagues, visitors and patients within the hospital, in addition to any specific risk management orclinical governance accountabilities associated with this post.
- To observe the rules, policies, procedures and standards of King's College Hospital NHS Trusttogether with all relevant statutory and professional obligations.
- To live and role model the Kings Values of: -Understanding you-Inspiring confidence in our care-Working together-Always aiming higher-Making a difference in our community
- 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 bedefinitive or restrictive. It is expected that some of the duties will change over time and this descriptionwill be subject to review in consultation with the post holder.
- All employees must hold an 'nhs.net' email account which will be the Trust's formal route for emailcommunication.
Safeguarding
The Trust takes the issues of Safeguarding Children, Adults and addressing Domestic Abuse very seriously.All employees have a responsibility to support the organisation in our duties by;-attending mandatory training on safeguarding children and adults- familiarising themselves with the Trust's processes for reporting concerns -reporting any safeguarding child or adult concerns appropriately
Infection control statement
The post holder has an important responsibility for and contribution to infection control and must be familiarwith the infection control and hygiene procedures and requirements when in clinical areas.The post holder has an important responsibility for and contribution to make to infection control and must befamiliar 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 andprocedures, which will be made clear during your induction and subsequent refresher training. Thesestandards must be strictly complied with at all times.
Person Specification
Edcuation and qualifications
Essential
- Nursing Degree Adult RN
- Evidence of continuous personal, professional and academic development
Desirable
- Relevant post registration qualification
- Post-graduate qualification with a research methodology element
- GCP qualification
Knowledge and experience
Essential
- Previous clinical research experience
- Previous post registration/post-graduate experience within the Liver department
Desirable
- Previous liver nursing experience
- Experience of collaborating with other agencies
- Knowledge and experience of handling complex relationships
Skills and competencies
Essential
- Understanding of Regulatory requirements pertaining to trials
- Excellent communication and interpersonal skills
- Ability to perform basic clinical skills (obtaining vital signs measurements)
- Ability to perform venepuncture and cannulation
- Evidence of accuracy to detail in data collection
- Ability to organise, prioritise and co-ordinate work of self and others
- Strong motivation to work within the field of Liver research
- Good team working skills
- Ability to work flexible hours as required
Desirable
- Report writing and presentational skills
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
- Line management experience
- Reasonable IT skills in the following areas: - Word processing - Communication software - all functions of MS Outlook - Internet searching - Spreadsheets - producing multi-sheet tables, graphs, sorting and filtering
Person Specification
Edcuation and qualifications
Essential
- Nursing Degree Adult RN
- Evidence of continuous personal, professional and academic development
Desirable
- Relevant post registration qualification
- Post-graduate qualification with a research methodology element
- GCP qualification
Knowledge and experience
Essential
- Previous clinical research experience
- Previous post registration/post-graduate experience within the Liver department
Desirable
- Previous liver nursing experience
- Experience of collaborating with other agencies
- Knowledge and experience of handling complex relationships
Skills and competencies
Essential
- Understanding of Regulatory requirements pertaining to trials
- Excellent communication and interpersonal skills
- Ability to perform basic clinical skills (obtaining vital signs measurements)
- Ability to perform venepuncture and cannulation
- Evidence of accuracy to detail in data collection
- Ability to organise, prioritise and co-ordinate work of self and others
- Strong motivation to work within the field of Liver research
- Good team working skills
- Ability to work flexible hours as required
Desirable
- Report writing and presentational skills
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
- Line management experience
- Reasonable IT skills in the following areas: - Word processing - Communication software - all functions of MS Outlook - Internet searching - Spreadsheets - producing multi-sheet tables, graphs, sorting and filtering
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)
