Research Nurse / Clinical Trials Coordinator
NHS AfC: Band 5
Main area: Haematology, Research Grade NHS AfC: Band 5
Contract: Fixed term: 12 months (FTC)
Hours: Full time - 37.5 hours per week
Job ref: 213-CORP-6867011
Employer: King's College Hospital NHS Foundation Trust
Employer type: NHS
Site: King's College Hospital
Town: London
Salary: £35,964 - £43,780 per annum, inc HCA
Salary period: Yearly
Closing: 30/12/2024 23:59
Job overview
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, predominantly with 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
* Work with the Lymphoma/Myeloma Team and wider haematology team to recruit patients onto clinical trials and undertake clinical responsibilities.
* Lead and maintain an 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.
Working for our organisation
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 Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, with Diversity, Equality and Inclusion at the heart of everything we do.
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.
Detailed job description and main responsibilities
Clinical Responsibilities
• Liaise with the clinical team to ensure that trial-specific investigations are undertaken according to the protocol and obtain the results.
• If appropriately trained, undertake agreed procedures, including 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.
• Ensure the confidentiality of verbal, written, and computerized information.
• Liaise with trial pharmacy to coordinate the availability and dispensing of trial drugs if required.
• Process blood samples according to the trial-specific lab manual and organize the storage and shipment of protocol-specific samples.
• Ensure adequate precautions are taken to minimize 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, and Human Tissue Act.
Organisational Responsibilities
• Complete case report forms in a precise and timely manner, ensuring that all relevant clinical data in the patient’s medical notes and trial file is transcribed accurately.
• Prepare the relevant documents required when submitting trial protocol and paperwork for regulatory review and approval.
• Process amendments and disseminate information to relevant departments.
• Create and maintain the file of current protocols and patient information sheets, ensuring version control.
• Maintain the Investigator Site Files.
• Deal with data queries in a timely and efficient manner.
• 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 Responsibilities
• 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 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.
• 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 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.
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 haematology/oncology or research
Skills and Competencies
* Clinical Skills: phlebotomy, ECG, Vital signs
* Data Collection, entry & filing
* Ability to work in a team
Employer certification / accreditation badges
This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.
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