Job summary
The post holder will be involved in the running of in-house, national and international phase I, II and III, CAR-T therapy haem-onc trials. The post holder will help coordinate patient participation in clinical trials, ensuring that trial specific investigations are undertaken according to the protocol. They will also be responsible for administrative aspects of the trial including the creation and maintenance of site files, formulating worksheets, collection of trial data and the completion of case report forms
Main duties of the job
Collect and provide information to allow for invoices to be raised for payments where appropriate.Liaise with other departments and wards to promote a good working environment, integration of research within clinical service and open channels of communication. Inform appropriate medical personnel and departments of portfolio of clinical trials. Updatethe Senior Research Nurse/Clinical Trials Practitioner regularly the status of each allocated study Prepare the relevant documents required when submitting trial protocol and paperwork for regulatory review and approval. Assist in completing submission to the REC, HRA and R&I Department. Process amendments and disseminate information to relevant departments.Formulate and maintain the databases for clinical trials. Resolve data queries in a timely and efficient manner. Formulatetrial-specific SmartPhrase worksheets for each trial on EPIC.Organise and prepare documentation for audit and monitoring visits.Provide information to allow invoices to be raised for payment where appropriate. Arrange, attend and record minutes for research and other relevant departmental meeting. Providecover when necessary for annual leave, study leave, sick leave including cover for Haematology Trials conducted at Princess Royal University Hospital Report adverse incidents and near misses via the Trust's online incident reporting form. Ensure all relevant documents and approvals are in place prior to subject recruitment.
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
Work in support / conjunction with the Senior Clinical Trials Coordinator/Clinical Trials Practitioner/Research Nurses to manage a number of trials, ensuring trial protocols and governance are strictly adhered to, managed within current UK clinical trial directives & regulations 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
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 trained, ensure these procedures are undertaken by suitably trained staff in line with trial and Trust procedures. It is anticipated the post holder will obtain training in these areas as appropriate to ensure effective delivery.
Ensure the confidentiality of verbal, written and computerised information.
Sample Processing & shipping, Liaising with pharmacy in IMP dispensing.
Admin tasks such as data entry, maintaining the TMF/ISF with essential documents
Attend relevant governance meetings.
Job description
Job responsibilities
Work in support / conjunction with the Senior Clinical Trials Coordinator/Clinical Trials Practitioner/Research Nurses to manage a number of trials, ensuring trial protocols and governance are strictly adhered to, managed within current UK clinical trial directives & regulations 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
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 trained, ensure these procedures are undertaken by suitably trained staff in line with trial and Trust procedures. It is anticipated the post holder will obtain training in these areas as appropriate to ensure effective delivery.
Ensure the confidentiality of verbal, written and computerised information.
Sample Processing & shipping, Liaising with pharmacy in IMP dispensing.
Admin tasks such as data entry, maintaining the TMF/ISF with essential documents
Attend relevant governance meetings.
Person Specification
Education and Qualifications
Essential
- Evidence of continuous personal, professional, and academic development
- GCP qualification
- Life Science degree or equivalent qualification/training/education relevant to post
Desirable
- Relevant post registration qualification
Knowledge and Experience
Essential
- Strong and demonstrable interpersonal skills with an ability to communicate with a diverse range of contacts, both internal and external to the organisation
- Ability to prioritise; to be organised and flexible.
Desirable
- Previous experience within haematology oncology; or research
Skills and Competencies
Essential
- Clinical Skills; phlebotomy, ECG, Vital signs
- Data Collection, entry & filing
- Ability to work in a team
- Ability to use Microsoft Office
- Excellent written and verbal communication skills
- Report writing and presentational skills
Person Specification
Education and Qualifications
Essential
- Evidence of continuous personal, professional, and academic development
- GCP qualification
- Life Science degree or equivalent qualification/training/education relevant to post
Desirable
- Relevant post registration qualification
Knowledge and Experience
Essential
- Strong and demonstrable interpersonal skills with an ability to communicate with a diverse range of contacts, both internal and external to the organisation
- Ability to prioritise; to be organised and flexible.
Desirable
- Previous experience within haematology oncology; or research
Skills and Competencies
Essential
- Clinical Skills; phlebotomy, ECG, Vital signs
- Data Collection, entry & filing
- Ability to work in a team
- Ability to use Microsoft Office
- Excellent written and verbal communication skills
- Report writing and presentational skills
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)
