Job summary
The post-holder will work as part of the RDU 9 Research Delivery team for Paediatric Research. The post holder will cover the workload and responsibilities of his/her colleagues during their absence. The post-holder will report to the Lead Research Nurse who will be responsible for managing the requirements and demands for research delivery support across the research programmes and themes. The post-holder will be based at the Paediatric 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 to monitor and update on EDGE, the recruitment for studies conducted at the PRUH. The post-holder will be involved in ensuring that any research undertaken at this recruiting site safeguards the well-being of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006. The post holder will undertake all relevant responsibilities as study co-ordinator and will ensure high quality of the research by maintaining high standards throughout the study as well as good data integrity. This includes commercial and non-commercial NIHR portfolio studies as well as investigator-led studies. As study coordinator, the post holder will be expected to report serious adverse events in a timely manner.
Main duties of the job
- Manage own study portfolio within the designated areas of responsibility.
- Maintain effective communication with patients, parents, carers and professionals to ensure service delivery.
- Adhere to King's Policy and procedures.
- Be responsible for the whole patient recruitment process from selection to screening and from randomisation to the scheduling of study visits.
- Evaluate patient eligibility for the trial during pre-screening. Liaising with the investigator. Co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to the Schedule of Events in the study protocols.
- Ensure patients are fully informed prior to entry into the clinical research programme. To provide ongoing advice and information to patients with regards to their participation in clinical research in order to facilitate effective informed consent.
- Offer support to patients and families, explaining practical aspects of the trial, assisting and supporting local nursing teams when necessary.
- Follow the principles of Good Clinical Practice (GCP) and ensure that the trial is conducted according to the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006 where appropriate.
- Maintain clear and accurate data when transcribing data onto electronic or paper case report forms.
About us
King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of £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
The successful candidate will have the opportunity to learn about research governance, ethics, study management and study delivery with an introduction to research finance.
All relevant and mandatory research training will be provided.
The successful candidate will be part of a team that manages a portfolio of challenging and interesting clinical trials in various disorders in Paediatric research.
The successful candidate will experience tasks such as patient recruitment, study assessments, blood collection and processing, data entry and data management alongside administrative tasks as needed for the clinical trials activities within RDU 9.
The post is focused on providing the successful candidate with experience in commercial and non-commercial clinical trials by carrying out research activities, aimed at improving the care and treatment of the paediatric patients.
The successful candidate will develop a close working relationship with the inpatient and outpatient support services and be invited to the clinical trial team meetings.
The successful candidate will work towards being proficient in managing his/her own research workload effectively and completing trial documentation accurately and in a timely manner.
If you would like an informal visit to find out more, please contact Katie Tupper 020 3299 2129 or via email: katietupper@nhs.net
Job description
Job responsibilities
The successful candidate will have the opportunity to learn about research governance, ethics, study management and study delivery with an introduction to research finance.
All relevant and mandatory research training will be provided.
The successful candidate will be part of a team that manages a portfolio of challenging and interesting clinical trials in various disorders in Paediatric research.
The successful candidate will experience tasks such as patient recruitment, study assessments, blood collection and processing, data entry and data management alongside administrative tasks as needed for the clinical trials activities within RDU 9.
The post is focused on providing the successful candidate with experience in commercial and non-commercial clinical trials by carrying out research activities, aimed at improving the care and treatment of the paediatric patients.
The successful candidate will develop a close working relationship with the inpatient and outpatient support services and be invited to the clinical trial team meetings.
The successful candidate will work towards being proficient in managing his/her own research workload effectively and completing trial documentation accurately and in a timely manner.
If you would like an informal visit to find out more, please contact Katie Tupper 020 3299 2129 or via email: katietupper@nhs.net
Person Specification
Education and Qualifications
Essential
Training
Desirable
- ICH-GCP
- HTA and Consent
- IATA
Experience
Essential
- Experience working in the clinical setting as an RN
Desirable
- Research experience
- Experience in liaising with study monitors and sponsors
- Experience in maintaining study data bases
- Experience in reporting SAEs within the 24-hour deadline
Knowledge
Essential
- Knowledge of NHS/clinical setting
- Awareness of the need for discretion and confidentiality
Desirable
- A good understanding of research governance and ethics
- Study set-up, delivery, completion
- Research Invoicing
Skills
Essential
- Good communication and personal skills
- Computer literacy and competence in standard PC packages.
Desirable
- Venepuncture and cannulation
Abilities
Essential
- Ability to work under pressure
- Ability to work independently and as part of a team
- Ability to impart study information to patients, relatives and carers, with different levels of understanding
- Ability to enter data onto sponsors' EDC systems accurately and in a timely manner
- Ability to interact sensitively and professionally with clinical staff and patients
Aptitude
Essential
- Adaptable and flexible
- Punctual and dependable
- Willing to learn new skills
- Maintains a professional image
- Motivated and enthusiastic
Person Specification
Education and Qualifications
Essential
Training
Desirable
- ICH-GCP
- HTA and Consent
- IATA
Experience
Essential
- Experience working in the clinical setting as an RN
Desirable
- Research experience
- Experience in liaising with study monitors and sponsors
- Experience in maintaining study data bases
- Experience in reporting SAEs within the 24-hour deadline
Knowledge
Essential
- Knowledge of NHS/clinical setting
- Awareness of the need for discretion and confidentiality
Desirable
- A good understanding of research governance and ethics
- Study set-up, delivery, completion
- Research Invoicing
Skills
Essential
- Good communication and personal skills
- Computer literacy and competence in standard PC packages.
Desirable
- Venepuncture and cannulation
Abilities
Essential
- Ability to work under pressure
- Ability to work independently and as part of a team
- Ability to impart study information to patients, relatives and carers, with different levels of understanding
- Ability to enter data onto sponsors' EDC systems accurately and in a timely manner
- Ability to interact sensitively and professionally with clinical staff and patients
Aptitude
Essential
- Adaptable and flexible
- Punctual and dependable
- Willing to learn new skills
- Maintains a professional image
- Motivated and enthusiastic
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).
