Clinical Research Nurse - Liverpool
To screen potential participants and assess patient eligibility for clinical trial entry To approach parents to introduce and discuss the study and to approach parents to gain informed consent after they have had time to consider the study To co-ordinate trial treatments, obtaining relevant supplementary data and arranging appropriate appointments as necessary according to the clinical trial protocol to ensure patient safety To attend appropriate clinics to promote study participation and screen and recruit new participants To ensure the safe administration of treatments and drugs given within the context of a clinical trial To ensure blood and/or other samples are collected and transported as required by the trial protocol To ensure that trial specific investigations are undertaken as required by the protocol To clinically assess and evaluate patients on the trial To maintain accurate, comprehensive and legible patient notes (written and electronic) of all clinical events in accordance with the Trust and national professional policies and guidelines To monitor and maintain accurate written and/or computer records with regards to physical and psychological changes/ treatment toxicity and side effects experienced by patients and taking appropriate action To record and report all adverse events that occur as part of the clinical trial in accordance with the protocol and delegated responsibilities To provide ongoing support and follow up care for the child and family whilst the child is in the clinical trial To carry out follow up checks and interventions as detailed in the trial protocol which may occasionally require visits to other sites or to patients own homes To collect follow up data from other wards according to the study protocol To act as a primary contact point (for trial issues) for the child and family for the duration of the trial To adhere to clinical departmental policies at all times Work in collaboration with other members of the multidisciplinary team to ensure the family and child fully understand the nature of the trial; his/her voluntary entry to the trial and freedom to withdraw at any time without prejudice to treatment 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 co-ordinating 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 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 identify, assess and meet the educational needs of the patient and the family to facilitate understanding and compliance with the trial protocol To provide teaching to members of clinical staff on the trial protocol procedures and items of equipment deemed necessary for the purposes of the trial 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 manner in which 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 hospitals policy and Health and Safety Work Act 1974 To maintain confidentiality at all times To comply with the Research Governance Framework 2005 To work alongside other research staff assigned to the study and other related studies as deemed appropriate and provide complementary support to the research team To maintain confidentiality at all times