Research Nurse / Clinical Trials Coordinator

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

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

Job description

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 on the status of such data. Prepare the relevant documents required when submitting trial protocol and paperwork for regulatory review and approval. Assist in completing submissions 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 meetings. Attend investigator meetings and conferences when required. Provide cover when necessary for annual leave, study leave, and 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 within 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

Essential

• NMC Level One Registration - RN Adult
• Evidence of continuous personal, professional, and academic development
• GCP qualification

Desirable

• Relevant post-registration qualification

Knowledge and Experience

Essential

• Knowledge and experience with multidisciplinary teams and internal & external stakeholders

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

Employer details

Employer name

King's College Hospital NHS Foundation Trust

Address

King's College Hospital

Denmark Hill

London

SE5 9RS

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