Job summary
The post holder will be responsible for data management and full administrative service to the Liver Clinical Trials team. The post-holder will also be supporting the team's portfolio of commercial and non-commercial clinical trials.
Responsibilities will include completion of case report forms, liaising with clinical trials Sponsors, day to day office management and maintenance of clinical trials documentation, processes and database.
The post holder will work closely with the liver research nurses, clinical trial coordinators, clinical team and clinical trials sponsors and representatives.
Main duties of the job
- Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
- Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
- Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsor's SOP.
- Assist in carrying out audit and monitoring activities related to research. This will mean assisting both internal and external monitors of research.
- To assist in adhoc tasks to support various developments, projects and events within the team.
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
1. Clinical Responsibilities
- Responsible for accurate completion of Case Report Forms (CRFs).
- Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
- Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
- Act as a resource and support to patients and their relatives, explaining practical aspects of clinical trials, assisting and supporting nursing teams.
- Act as a resource for liver based research.
- Work in accordance with all regulatory requirements including:
- Local Standard Operating Procedures (SOPs)
- Good Clinical Practice
- Medicines for Human Use (Clinical Trials) Regulations
- Research Governance Framework for Health and Social Care
- Human Tissue Act
2. Portfolio Management and Development
- Maintain the TMF/ISF with essential documents.
- Help and organise initiation meetings.
- Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up of patient under the supervision of clinical trial coordinator.
- Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsors SOP.
- 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.
- Report adverse incidents and near misses via the Trusts online incident reporting form.
- Act as a link for Liver Clinical Trials team and KHPCTO and KCH R&I Department
- To organise and issue documents to visiting Sponsors and affiliates
- To contribute to the writing and maintaining of SOPs that cover the areas of responsible work, as supervised by the CTC.
- Assist in carrying out audit and monitoring activities related to research. This will mean assisting both internal and external monitors of research
3. Office Management
- Arrange and provide administrative support for meetings, including minute taking, preparing agendas and following up actions, compiling and distributing papers, booking meeting rooms and arranging catering, providing travel directions and acting as the first point of contact for members regarding meeting arrangements and attendance. This may require travel to and attendance at meetings at different locations within KCH, and other Trusts.
- Ensure the availability of office supplies, furniture and equipment and procurement of goods for the Clinical Trials team.
- Act as first point of contact for callers to the Liver Clinical Trials Team, and for telephone and written enquiries.
- Assist in organising patient appointments
- Manage an effective system for processing patient travel claims and liaising with Finance Department
- Type correspondence, memos, e-mails and other documents from audiotape, written copy, dictation or verbal instructions, and to generate own correspondence as required.
- File correspondences from Sponsors, and any patient related activity.
- To assist in adhoc tasks to support various developments, projects and events within the team.
- Ensure that accrual data is uploaded onto the UKCRN portal/EDGE and is reported to the SELCRN co-ordinating centre as required
3. Training and Development
- Attend the KHPCTO and KCH R&D Department 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 treatments, research and nursing practice and use this knowledge to maintain high standards of care
- 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.
- Demonstrate the use of database systems and train colleagues and researchers.
4. Professional
- Actively participate in personal development together with line manager. Ensure performance is appraised following the Trust appraisal and KAD procedures.
- Develop a clear understanding of the service and the role. Also able to provide cover for colleagues in the area when necessary
- Attend the KHPCTO and KCH R&D Department training programmes and other relevant education and training days/programmes as appropriate.
- Attend investigator meetings and conferences when required.
5. General responsibilities
- 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 Kings 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.
- Collect and provide information to allow for invoices to be raised for payments where appropriate
- Support the Senior Clinical Trials Coordinator in the management of agreements, to include obtaining signatures, sharing documents by email and post, and tracking workload, processing all in an efficient and timely way to ensure expedience, as directed by the CTC and Research Facilitator.
- Coordinate with support departments such as Radiology, histology and pathology to collect up to date treatment costs to form part of the Clinical Trials Agreement contract.
Job description
Job responsibilities
1. Clinical Responsibilities
- Responsible for accurate completion of Case Report Forms (CRFs).
- Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
- Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
- Act as a resource and support to patients and their relatives, explaining practical aspects of clinical trials, assisting and supporting nursing teams.
- Act as a resource for liver based research.
- Work in accordance with all regulatory requirements including:
- Local Standard Operating Procedures (SOPs)
- Good Clinical Practice
- Medicines for Human Use (Clinical Trials) Regulations
- Research Governance Framework for Health and Social Care
- Human Tissue Act
2. Portfolio Management and Development
- Maintain the TMF/ISF with essential documents.
- Help and organise initiation meetings.
- Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up of patient under the supervision of clinical trial coordinator.
- Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsors SOP.
- 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.
- Report adverse incidents and near misses via the Trusts online incident reporting form.
- Act as a link for Liver Clinical Trials team and KHPCTO and KCH R&I Department
- To organise and issue documents to visiting Sponsors and affiliates
- To contribute to the writing and maintaining of SOPs that cover the areas of responsible work, as supervised by the CTC.
- Assist in carrying out audit and monitoring activities related to research. This will mean assisting both internal and external monitors of research
3. Office Management
- Arrange and provide administrative support for meetings, including minute taking, preparing agendas and following up actions, compiling and distributing papers, booking meeting rooms and arranging catering, providing travel directions and acting as the first point of contact for members regarding meeting arrangements and attendance. This may require travel to and attendance at meetings at different locations within KCH, and other Trusts.
- Ensure the availability of office supplies, furniture and equipment and procurement of goods for the Clinical Trials team.
- Act as first point of contact for callers to the Liver Clinical Trials Team, and for telephone and written enquiries.
- Assist in organising patient appointments
- Manage an effective system for processing patient travel claims and liaising with Finance Department
- Type correspondence, memos, e-mails and other documents from audiotape, written copy, dictation or verbal instructions, and to generate own correspondence as required.
- File correspondences from Sponsors, and any patient related activity.
- To assist in adhoc tasks to support various developments, projects and events within the team.
- Ensure that accrual data is uploaded onto the UKCRN portal/EDGE and is reported to the SELCRN co-ordinating centre as required
3. Training and Development
- Attend the KHPCTO and KCH R&D Department 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 treatments, research and nursing practice and use this knowledge to maintain high standards of care
- 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.
- Demonstrate the use of database systems and train colleagues and researchers.
4. Professional
- Actively participate in personal development together with line manager. Ensure performance is appraised following the Trust appraisal and KAD procedures.
- Develop a clear understanding of the service and the role. Also able to provide cover for colleagues in the area when necessary
- Attend the KHPCTO and KCH R&D Department training programmes and other relevant education and training days/programmes as appropriate.
- Attend investigator meetings and conferences when required.
5. General responsibilities
- 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 Kings 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.
- Collect and provide information to allow for invoices to be raised for payments where appropriate
- Support the Senior Clinical Trials Coordinator in the management of agreements, to include obtaining signatures, sharing documents by email and post, and tracking workload, processing all in an efficient and timely way to ensure expedience, as directed by the CTC and Research Facilitator.
- Coordinate with support departments such as Radiology, histology and pathology to collect up to date treatment costs to form part of the Clinical Trials Agreement contract.
Person Specification
Knowledge and experience
Essential
- Experience in a complicated admin role involving data
- Evidence of organisational and time management skills
- Evidence of ability to work independently and as part of a MDT
- Ability to work under pressure in a high paced environment
- Understanding of medical research
- Over one years expereicne in a healthcare setting
Desirable
- Experience using clinical trials databases
- Evidence of synthesising data, report writing etc
- Has worked on commercial clinical trials
Education, Quals and Training
Essential
- relevent degree
- Proven advanced computer skills
Desirable
Person Specification
Knowledge and experience
Essential
- Experience in a complicated admin role involving data
- Evidence of organisational and time management skills
- Evidence of ability to work independently and as part of a MDT
- Ability to work under pressure in a high paced environment
- Understanding of medical research
- Over one years expereicne in a healthcare setting
Desirable
- Experience using clinical trials databases
- Evidence of synthesising data, report writing etc
- Has worked on commercial clinical trials
Education, Quals and Training
Essential
- relevent degree
- Proven advanced computer skills
Desirable
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).
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).
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)
