King's College Hospital NHS Foundation Trust
An exciting opportunity has become available with the vibrant Liver Research Team at King's College Hospital for a band 6 clinical research nurse. As a member of the Liver Research team, you will be based at King's College Hospital, Denmark Hill. The Liver Research team at the Institute of Liver Studies in King's College Hospital has an impressive portfolio that covers a wide range of studies, including observational cohort studies and interventional trials (phase 1-3) for various liver diseases. The team has gained a reputation for excellence in research delivery. We are looking for a highly motivated and experienced clinical research nurse to join our team. In this role, you will be responsible for coordinating and conducting clinical research activities, such as participant recruitment, data collection and analysis, and ensuring compliance with study protocols and regulatory requirements. To be successful in this role, you should have a proven track record in clinical research, including experience in various research methodologies and a strong understanding of Good Clinical Practice guidelines. Excellent communication and interpersonal skills are essential as you will be working with a diverse range of individuals, including patients, researchers, and industry partners.
Main duties of the job
You will be part of the team of liver research nurses to deliver the non-commercial trials and commercial trials within the portfolio, in accordance with the principles of GCP. This will include important trials with a national profile in liver diseases that are both challenging and interesting. The successful candidate will be expected to appropriately manage participants throughout the research pathway; as well as assume administrative responsibility for allocated projects. This will include study and data management activities, with close supervision by the senior research nurse.
You will interact with all relevant members of the multidisciplinary team to ensure that all research related activity is undertaken with patient safety as a key priority and that all projects are delivered efficiently, with adherence to time and target.
Excellent communication skills and willingness to learn are essential qualities in the successful applicant. Knowledge of related disease is desirable. For this post you must demonstrate the ability to manage your own workload; understand clinical trial activity and GCP and be able to complete trial documentation accurately and in a timely manner.
Job responsibilities
Clinical Responsibilities
- Work in conjunction with the Senior Research Nurse/Clinical Trials Coordinator to manage a caseload of patients, whilst working as part of a multidisciplinary team. Maintain effective communication with patients, carers and professionals to ensure service delivery. Assist in screening patients suitable for entry into clinical trials. This may include attending clinics and Multidisciplinary Team (MDT) meetings.
- Identify patients suitable for entry into clinical trials by attending clinics (screening notes/consultant referral) and Multidisciplinary Team (MDT) meetings.
- With other members of the healthcare team, ensure patients are fully informed prior to entry in any clinical trial programme.
- Assist in consenting, randomising, allocating of treatment of patients.
- Evaluate patient eligibility for clinical trial entry, co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to trial protocol.
- Act as a resource and support to patients and their relatives, explaining practical aspects of clinical trials, assisting and supporting local nursing teams.
- Coordinate the collection of any blood samples required as part of the clinical trials and ensure safe and appropriate storage of specimens, in conjunction with local nursing teams.
- Support the administration of trial drugs (commensurate with education and training), be aware of and report any unusual side effects, in association with local nursing teams.
- Maintain adequate patients records and ensure all relevant information is documented in the patients medical and nursing notes.
- Responsible for accurate completion of Case Report Forms (CRFs).
- Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials.
- Provide continuity of care for patients and their carers throughout the trial programme. Provide specific advice and support as appropriate.
- Implement and adhere to the principles of GCP (Good Clinical Practice) as set out in the Clinical Trials Regulations.
- If appropriately trained, keep up to date with current practices for cannulation, phlebotomy and care of patients with Central Venous Access lines.
- Act as a resource for liver based research.
Portfolio Management and Development
- Assist in the review of trial protocols and identify resource implications for the site.
- Set up and maintain the TMF/ISF with essential documents.
- Liaise with and assist the medical team/sponsor organisation in - on-study treatment and follow up of patient.
- Ensure CRFs are completed accurately and in a timely manner.
- Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsors SOP.
- For network trials, ensure that accrual data is uploaded onto the NIHR CRN portal using the EDGE clinical trials database. Collect and provide information to allow for invoices to be raised for payments where appropriate.
- Liaise with other departments and wards at the site/s, in order to promote a good working environment, integration of research within and open channels of communication.
- Inform appropriate medical personnel and departments of portfolio of clinical trials.
- Participate in the presentation of research findings within the Clinical Research Network South London and outside agencies as appropriate.
- Report adverse incidents and near misses via the Trusts online incident reporting form.
- Coordinate multi-centre trials (where appropriate). Together with the Kings Health Partners Clinical Trials Office (KHP CTO):
- Ensure all relevant documents and approvals are in place at each site prior to subject recruitment.
- Liaise with participating sites, identifying key staff and updating them on trial processes/changes to the protocol and ensuring centres are able to comply with the study protocol.
- Help conduct initiation meetings (if required).
- Collect data from sites, raise data queries and ensure data queries are resolved.
Training and Development
- Attend the KHP CTO, NIHR CRN and CRN South London training programmes and other relevant education and training days/programmes as appropriate.
- Attend investigator/initiation meetings and conferences when required.
- Maintain awareness of current advances in hepatology treatments, research and nursing practice and use this knowledge to maintain high standards of care for Nurse trial patients.
- Disseminate research by assisting in the preparation of posters/research papers for meetings, conferences and publications. Also circulate trial information and carry our presentations locally.
Person Specification
Education / Qualification
- Nursing Degree Adult RN
- Evidence of continuous personal, professional and academic development
Research Experience
- Previous clinical research experience
- Previous post registration/post-graduate experience within the Liver department
- Knowledge and experience of handling complex relationships
Skills and competencies
- Understanding of Regulatory requirements pertaining to trials
- Excellent communication and interpersonal skills
- Ability to perform basic clinical skills (obtaining vital signs measurements)
- Ability to perform venepuncture and cannulation
- Report writing and presentational skills
- Ability to work across boundaries, integrating with multidisciplinary staff in relation to clinical trials
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
£44,806 to £53,134 a year per annum inc HCA's