Job summary
The post holder will be responsible for recruiting to, and following up, patients in trials and studies adopted by the National Institute of Health Research (NIHR).
The post-holder will be based at the Stroke Research Office at King's College Hospital and work in close liaison with the principal investigators at King's College Hospital NHS Foundation Trust and at the Princess Royal University Hospital (PRUH) site in Orpington. The post-holder will be required, on occasions, to see study patients and to recruit new patients into studies, at the PRUH.
Main duties of the job
The post holder will be responsible for co-ordinating a portfolio of non-commercial and commercial clinical trials. Key responsibilities will include patient screening and recruitment, collecting data and data entry, supporting and monitoring patients, ensuring trials are set up and managed in accordance with regulatory, sponsor and local Research & Innovation (R&I) requirements.
The post holder will be expected to attend thrombolysis calls in A&E, attend ward rounds and multi-disciplinary meetings to help identify participants suitable for entry into trials. The post holder is expected to work as part of a team and at times autonomously, ensuring research governance and patient safety are prioritized at all times.
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 Stroke Research Manager, Research Nurse, Clinical Trials Coordinator, medical staff, the Clinical Nurse Specialist Teams, the, radiologists and the pharmacy technicians.
As a qualified nurse, the post holder may be delegated the responsibility for preparation/administration of trial drugs and will work closely with within the wider nursing team to ensure all drug administration and other clinical nursing responsibilities are both in line with the trial 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£1.8 billion, 1.5 million patient contacts a year and around 15,000 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.
Job description
Job responsibilities
Clinical Responsibilities
- Work in support / conjunction with the Stroke Research Manager and wider team 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 trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings
- Be aware of and on occasion (if trained and delegated the duty) participate in the informed consent process
- Support and help coordinate the research patient pathway from screening through to 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
- 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 stroke-based research
Portfolio Management and Development
- Review trial protocols and support Research Manager to identify resource implications for site
- Liaise with the clinical trial lead, medical team/sponsor organisation to co-ordinate the on-study treatment and patient follow up
- Liaise with Clinical Trial Set Up staff to help assist in the set-up of trials on site
- Assist in completing submissions to Research & Development departments of relevant sites
- Process amendments and disseminate information to relevant departments
- Ensure that accrual data is reported to the Sponsors as required
- Provide information to allow for invoice 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 Clinical Trial lead 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
- Support the development and implementation of strategies to increase patient recruitment and promote profile of stroke research
- To innovate and contribute to the development of network wide clinical and research policies and procedures
- To support the Stroke Research services goal to accrual targets for both CLRN 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 development plan
General
- The post holder has a general duty of care for their own health, safety and wellbeing 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.
- We want to be an organisation where everyone shares a commitment to delivering the very best care and feels like their contribution is valuable and valued.
- At Kings we are a kind, respectful team:
- Kind. We show compassion and understanding and bring a positive attitude to our work
- Respectful. We promote equality, are inclusive and honest, speaking up when needed
- Team. We support each other, communicate openly, and are reassuringly professional
- 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.
- All employees must hold an 'nhs.net' email account which will be the Trust's formal route for email communication.
- Everyone is responsible for promoting inclusion no matter their role or team. At Kings, we want to create an environment where everyone feels valued, respected and welcomed
Safe Guarding
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 familiar with 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 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.
Job description
Job responsibilities
Clinical Responsibilities
- Work in support / conjunction with the Stroke Research Manager and wider team 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 trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings
- Be aware of and on occasion (if trained and delegated the duty) participate in the informed consent process
- Support and help coordinate the research patient pathway from screening through to 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
- 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 stroke-based research
Portfolio Management and Development
- Review trial protocols and support Research Manager to identify resource implications for site
- Liaise with the clinical trial lead, medical team/sponsor organisation to co-ordinate the on-study treatment and patient follow up
- Liaise with Clinical Trial Set Up staff to help assist in the set-up of trials on site
- Assist in completing submissions to Research & Development departments of relevant sites
- Process amendments and disseminate information to relevant departments
- Ensure that accrual data is reported to the Sponsors as required
- Provide information to allow for invoice 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 Clinical Trial lead 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
- Support the development and implementation of strategies to increase patient recruitment and promote profile of stroke research
- To innovate and contribute to the development of network wide clinical and research policies and procedures
- To support the Stroke Research services goal to accrual targets for both CLRN 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 development plan
General
- The post holder has a general duty of care for their own health, safety and wellbeing 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.
- We want to be an organisation where everyone shares a commitment to delivering the very best care and feels like their contribution is valuable and valued.
- At Kings we are a kind, respectful team:
- Kind. We show compassion and understanding and bring a positive attitude to our work
- Respectful. We promote equality, are inclusive and honest, speaking up when needed
- Team. We support each other, communicate openly, and are reassuringly professional
- 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.
- All employees must hold an 'nhs.net' email account which will be the Trust's formal route for email communication.
- Everyone is responsible for promoting inclusion no matter their role or team. At Kings, we want to create an environment where everyone feels valued, respected and welcomed
Safe Guarding
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 familiar with 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 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.
Person Specification
Education and Qualifications
Essential
- Nursing Degree NMC Level 1 Registration
- Post registration work experience in a clinical setting
- ICH-GCP qualification
Desirable
- Post Graduate Qualification in relevant field
Knowledge and Experience
Essential
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
Desirable
- Previous Experience working with Stroke patients
- Previous Clinical Research experience
- Understanding of Regulatory requirements pertaining to trials
Skills and Competencies
Essential
- Ability to perform venepuncture and cannulation
- Excellent communication and interpersonal skills
- Ability to perform basic clinical skills (obtaining vital signs measurements and ECG)
- 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
- Evidence of accuracy to detail in data collection
Desirable
- Report writing and presentational skills
Additional Information
Essential
- Ability to work flexible hours as required
Person Specification
Education and Qualifications
Essential
- Nursing Degree NMC Level 1 Registration
- Post registration work experience in a clinical setting
- ICH-GCP qualification
Desirable
- Post Graduate Qualification in relevant field
Knowledge and Experience
Essential
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
Desirable
- Previous Experience working with Stroke patients
- Previous Clinical Research experience
- Understanding of Regulatory requirements pertaining to trials
Skills and Competencies
Essential
- Ability to perform venepuncture and cannulation
- Excellent communication and interpersonal skills
- Ability to perform basic clinical skills (obtaining vital signs measurements and ECG)
- 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
- Evidence of accuracy to detail in data collection
Desirable
- Report writing and presentational skills
Additional Information
Essential
- 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).
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)
