Research Nurse / Clinical Trials Coordinator

Research Nurse / Clinical Trials Coordinator

King's College Hospital NHS Foundation Trust

The successful post holder will be involved in the delivery of Multicentre trials, in-house, national and international phase I, II, III and IV haematology trials. The role will predominantly be involved in the Lymphoma/Myeloma Team

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

• Working with the Lymphoma/Myeloma Team and wider haematology team to recruit patients onto clinical trials and undertake clinical responsibilities.
• The successful post holder will be expected to lead and maintain overview of various clinical trials.
• Sample collection, processing and shipment.
• Data collection and entry into various sponsor -led portals.
• Administrative duties including organising and attending study meetings, maintenance of Investigator Site File, regulatory review and approval.

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 billion, 1.5 million patient contacts a year and more than 15,000 staff based across South East London. The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reachis 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 responsibilities

Clinical Responsibilities Liaise with the clinical team to organise and ensure that trial specific investigations are undertaken according to the protocol and obtain the results. If appropriately trained, undertake agreed procedures, in line with trial and Trust procedures, to include: venipuncture, temperature, pulse, blood pressure checks, ECGs, height, weight, urinalysis and measuring O2 stats 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.

Liaise with trial pharmacy to co-ordinate the availability and dispensing of trial drugs if required. Take (if appropriately qualified) and process blood samples according to the trial specific lab manual and organise the storage and shipment of protocol specific samples. 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. 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

Organisational Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the patients medical notes and trial file is transcribed accurately. To update the Senior Research Nurse/Clinical Trials Practitioner regularly the status of such data 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. Create and maintain the file of current protocols and patient information sheets, ensuring version control. Be responsible for the maintenance of the Investigator Site Files. Formulate and maintain the databases for clinical trials. Deal with data queries in a timely and efficient manner. Formulate trial-specific worksheets for each trial. 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. Attend investigator meetings and conferences when required. Provide cover when necessary for annual leave, study leave, sick leave.

Report adverse incidents and near misses in line with Trust policy.

Education and Training Take responsibility for identifying personal training and educational needs with the context of the service and those identified during the appraisal process. Attend investigator meetings and conferences when required.

GENERAL 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 King's 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. 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. The post holder has an important responsibility for and contribution 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 Qualification

• Evidence of continuous personal, professional, and academic development

Knowledge and Experience

• Knowledge and experience with Multidisciplinary team and internal & external stakeholders
• Previous experience within haematologyoncology; or research

Skills and Competencies

• Clinical Skills ; phlebotomy,ECG, Vital signs
• Data Collection, entry & filing
• Ability to work in a team

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.

King's College Hospital NHS Foundation Trust

£35,964 to £43,780 a yearper annum, inc HCA