Research Nurse - Liver RDU

Job overview

The post holder will be part of a team of Liver research nurses running commercial and non commercial clinical trials in the Liver research department. The scope of work undertaken within the unit spans the spectrum from pre-clinical investigator led activity to phase 1, 2 and 3 studies.

Responsibilities will include co-ordinating patient activity and overseeing patient care at all stages of the research pathway; data management (collecting data, entering data and resolving discrepancies) and working with clinical research organisations and sponsors to satisfy audit and monitoring requirements. With respect to multi-centre trials sponsored by KCH, the post holder will be expected to support investigators and their teams at recruiting sites.

The post holder will work closely with the multidisciplinary team, including but not restricted to the Research Manager, Senior Research Nurse, Liver clinicians, the Clinical Nurse Specialist Teams, radiologists and the pharmacy technicians.

Main duties of the job

• To provide safe, patient-centred nursing care to patients participating in clinical research within the Liver Research Delivery Unit (RDU), ensuring their clinical needs and wellbeing are met throughout their involvement in research studies.
• To coordinate and deliver clinical research studies in hepatology, including screening and recruitment, obtaining informed consent etc, in line with study protocols and Good Clinical Practice (GCP).
• To support the Senior Research Nurse and wider nursing team in maintaining high standards of clinical care, meeting targets, research governance and patient safety.
• To support the training and development of the clinical team, sharing knowledge and promoting awareness of research within the department.
• To participate in clinical audit, research and service improvement activities
• To work closely with principal investigators, hepatology clinicians, research teams and study sponsors to support the smooth running of clinical trials and resolve issues that may arise.
• To maintain accurate clinical records and study documentation, ensuring information is recorded in a timely manner and complies with confidentiality, governance and regulatory requirements.
• To identify and escalate clinical concerns, adverse events and protocol deviations, ensuring these are managed and reported appropriately to protect patient safety and maintain the quality of research data.

Detailed job description and main responsibilities

Clinical Responsibilities

• Work in conjunction with the senior research nurse 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.
• 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.
• Help the team to evaluate patient eligibility for clinical trials entry by co-ordinating pre-study tests, obtaining results and arranging appropriate appointments according to trial protocol.
• Coordinate all ongoing study visits and investigations as per the 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. You will retain overall responsibility and accountability for direct patient care; under supervision of the senior research nurse

Maintain adequate patients’ records and ensure all relevant information is documented in the patient’s 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.
• Liaise with and assist the medical team/sponsor organisation with on-study treatment and follow up of patients
• Ensure CRFs are completed accurately and in a timely manner.
• Ensure SAEs are recorded and reported in accordance with the protocol and/or sponsor’s SOP.
• Ensure that all accrual data is uploaded onto the EDGE database (the trust reporting system for all clinical trial activity undertaken within KCH).
• For KCH sponsored studies, ensure upload off data for all centres to the network co-ordinating centre as required.
• 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 the trust and open channels of communication.
• Raise awareness of the portfolio of current Liver clinical trials within the organisation.
• Participate in the presentation of research findings within the Clinical Research Network and outside agencies as appropriate.
• Report adverse incidents and near misses via the Trust’s online incident reporting form.
• Help to coordinate multi-centre trials. Together with the KHP Clinical Trials Office (KHPCTO):
• Ensure all relevant documents and approvals are in place at each site prior to subject recruitment.
• Help conduct initiation meetings (if required)
• Collect data from sites, raise data queries and ensure data queries are resolved.

Training and Development

• Attend the KHPCTO, NIHR 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 Liver treatments, research and nursing practice and use this knowledge to maintain high standards of care for 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.

Professional

• Act in accordance with local policies and procedures laid down by King’s College Hospital.
• Be responsible for maintaining a professional profile.
• Work within the NMC Scope of Professional Practice, Conduct and Record Keeping.
• Undertake an annual appraisal (internal performance review) to identify organisation and professional objectives and development needs.

Applicant requirements

You must have appropriate UK professional registration.

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.