NursingNetUK

Detailed job description and main responsibilities

• To develop an in-depth knowledge of the relevant clinical trials in order to support recruitment and trial delivery according to GCP standards
• To contribute to the trial set up process with attention to standard operating procedures and standard visit templates for use by other members of staff.

• Undertake extended roles in relation to the demands of the individual studies.
• To attend multidisciplinary team meetings in order to identify patients eligible for the clinical trials available.
• To act as a resource to members of the MDT, including promotion and eligibility of available clinical trials, both at Alder Hey and elsewhere in the ECMC network as appropriate.

• To assess patient eligibility for clinical trial entry
• To approach parents to discuss the study and where appropriate gain informed consent after they have had time to consider the study
• To co-ordinate the care and support of their own case load of clinical trial participants
• To work collaboratively with the principle investigator to co-ordinate trial visits according to the schedule of trial events, obtaining relevant supplementary data
• To contribute to the safe administration of trial interventions

• To ensure blood and other samples are collected for pharmacokinetic studies according to the study protocol.
• To support trial related safety monitoring and reporting of adverse events
• To develop a clear understanding of trial recommended management of treatment toxicity with any suggested changes to treatment.
• To be become conversant with the CTCAE gradings of toxicities.

• To clinically assess and evaluate patients on the trial and provide in hours support for patient/carer queries.
• To maintain accurate, comprehensive and legible patient notes (written and electronic) of all clinical events and contacts in accordance with the Trust and national professional policies and guidelines
• To carry out trial follow up visits and interventions as detailed in the trial protocol, which may occasionally require visits to other sites or to patient’s own homes
• To collect follow up data according to the study protocol

• To provide on-going information, education and support to children, carers and families regarding clinical studies.

• To adhere to clinical departmental policies at all times
• To contribute along with colleagues to the bi-weekly regional relapse panel discussions and data submission

Research

• To be responsible for the operational management of the study in accordance with the UK Policy Framework for Health and Social Care Research 2018, ICH Good Clinical Practice (ICH GCP), the Caldicott Guardian, Medicines for Human Use (Clinical Trials) Regulations, Data Protection Act 1998 and other local policies and procedures.
• To work alongside clinicians and other nurses to develop strategies to overcome barriers to recruitment
• To assist with the recruitment and randomisation if appropriate of eligible children into the clinical study
• To facilitate the informed consent of a participant (appropriate to age and understanding) during the recruitment process in accordance with ICH GCP and other guidelines
• To be responsible for forwarding study data in a timely manner to the trial coordinating Centre when requested and in accordance with the trial protocol
• To accurately document data collected into the case report forms (CRF)
• To assist in the maintenance of the trial databases, ensuring that all reporting of data is documented and stored in the correct manner
• To provide support to the Principal Investigator(s) to ensure that study data is appropriately archived
• To keep the Principal Investigator, other appropriate members of the trial team informed of the progress of the trial, supplying data to them as required
• To be aware of ethical considerations of research and act as the patients advocate at all times
• To be fully conversant and compliant with the requirements of the clinical trial protocol in relation to patient management, data collection and safety reporting
• To work closely with and in support of the Principle Investigator(s) and other Research Personnel involved in all aspects of the trial
• To ensure data is accessed in accordance with both the Data Protection Act and the Caldicott Guardian
• To ensure Trust R&D management approval is in place prior to commencing a study.
• To contribute to data submission required for the ECMC trial finder and annual report.

Education and Training

• To act as a resource for local staff at participating sites in relation to clinical trials
• To maintain an awareness of current advances in paediatric treatments, research and nursing practice within the relevant speciality
• To continue professional development, keeping updated with current clinical practice to maintain professional registration
• To maintain links with other trial nurses to develop and share knowledge and to provide mutual support
• To attend local and national meetings/training events as deemed necessary for the role, including mandatory GCP training
• To contribute to the national/inter-national network of oncology research nurses
• To identify, assess and meet the educational needs of the patient and the family to facilitate understanding and compliance with the trial protocol
• To identify, assess and meet the educational needs of other members of hospital/team staff to facilitate understanding and compliance with the trial protocol
• To act as an ambassador for the Oncology and trust wide research team, participating in events which promote its work.

Communication

• To provide highly specialised advice to patients and their families concerning the care and treatment during participation in the trial
• To provide information and education in a way that is suitable for the child, their carers and families, including the way the information is disseminated, complexity and language used and the timing of its giving
• To be responsible for maintaining strong relationships and positive communication channels with all participating members of the study and staff involved
• To ensure all communication is evidenced and documented as required by governance standards

Other

• To understand and adhere to local Trust policies and procedures.
• To act in accordance with the NMC Professional Code of Conduct
• The post holder has responsibility for safety as outlined in the hospital’s policy and Health and Safety Work Act 1974
• To maintain confidentiality at all times
• To comply with the Research Governance Framework 2005
• To work collaboratively alongside other research staff to support delivery of the provide complementary support to the research team
• To understand and contribute to the research relevant quality requirements as specified in the national NHS cancer services programme

Other information

Alder Hey Children’s NHS Foundation Trust is a dynamic organisation, therefore changes in the core duties and responsibilities of the role may be required from time to time. These guidelines are not a term or condition of contract.

We expect all our staff to share the values that are important to the Trust and behave in a way that reflect these. In keeping with the Trust’s Personal Responsibility Framework and the Equal Opportunities policy, the post holder is at all times expected to take responsibility for their own actions, support multidisciplinary and partnership working and develop a working environment of courtesy, fairness and mutual respect.