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.
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. Update the 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. Formulate trial-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. Provide cover 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.
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.
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.