Job responsibilities
Clinical: To assist in the co-ordination and facilitation of clinical study participants with support from the Band 6 Research nurses. Undertake extended roles in relation to the demands of the individual studies. To attend multi-disciplinary meetings, and appropriate clinics, to screen and recruit new participants, and to act as a resource to the members of the MDT. To ensure the safe administration of treatments and drugs that are administered within the context of a clinical study. To ensure that study specific investigations are undertaken as required by the study protocol, in order to establish eligibility and safety to enter the study. To provide on-going information, education and support to children, carers and families regarding clinical studies. To ensure blood and other samples are collected as required by the study protocol. To maintain accurate documentation of clinical events. To accurately document data collected in to the case report forms (CRF). To support monitoring and reporting treatment toxicity/side effects and initiate changes to treatment as required by the protocol. To record and report adverse events that occur whilst the child is in the clinical study to the relevant personnel and act as required. To report and record serious adverse events that occur whilst the child is in the clinical study to the Band 6 Research nurses, Study Coordinator/Principal Investigator (PI) and relevant local personnel/regulatory authorities. To provide on-going follow up care whilst the child is in the clinical study. To refer to other specialists as required providing optimal care for the child. To act as a primary contact point (for study issues) for the child and family in a clinical study.
Research: To assist in the management of a portfolio of clinical studies with assistance from the research team. To assist the team in identifying strategies for recruiting children to clinical studies. To ensure that clinical study protocols are adhered to. To ensure that you work according to Good Clinical Practice (GCP) and research governance standards for clinical studies. To ensure Trust R&D management approval is in place prior to commencing a study. To support and facilitate the informed consent process (appropriate to age and understanding) ensuring the following are encountered for:-o The child (and significant others) fully understand the nature of the clinical study.o The child is aware that entry into the study is voluntary and they can withdraw at any point without prejudiceo The child is aware of any extra procedures required by the study.o The consent form is completed accurately and filed as required. To be support forwarding study data in a timely manner to the appropriate place. To liaise with clinical study personnel outside of the hospital as necessary. To supply data as required to the Research Team/Clinical Manager regarding the progress of clinical studies. To register/randomise children into studies. To identify barriers to recruitment to studies and ensure that the Research Team/Clinical Manager are aware of these. Implement action/plans are required. To provide support for clinical study colleagues in their absence. To attend meetings relevant to the nature of the job.
ADMINISTRATION: To ensure that clinical study recruitment records are accurately maintained. To access the computer network as required retrieving relevant information. To ensure that clinical studies are effectively archived as required.
EDUCATION AND TRAINING: To identify youre learning needs in relation to a specialist area of practice. To support development and evaluation of teaching/learning resources for junior members of staff/ clinical teams To act as a resource for colleagues in relation to clinical studies. To work with the Research Team and Clinical Team to help ensure that all relevant health care professionals are educated and supported as required, enabling them to care for children in clinical studies. To maintain an up-to-date knowledge of the paediatric articles related to the clinical studies you are leading on. To continue your own professional development, keeping updated with current practice and maintaining PREP requirements. To maintain links with other clinical research nurses to develop and share knowledge and to provide mutual support. To attend national meetings in relation to clinical studies as appropriate and agreed by the Clinical Research Nurse Team Leader. To maintain an awareness of current advances in paediatric treatments, research and nursing practice and uses this knowledge to maintain the highest standard of care in children.
MANAGERIAL: To act as a mentor/preceptor for junior members of the team and facilitate their developmentthrough challenge and support. To contribute to the development of clinical and research policies/procedures/standard operating procedures. To undertake an agreed link role, cascading information and helping to organise training as required e.g. infection control link, resuscitation, child protection. To act as an ambassador for research and the Trust wide research team, participating in events which promote its work.
OTHER: To understand and adhere to Trust policies and procedures. To act in accordance with NMC Code of Professional Conduct. To ensure that trust wide standards are maintained and monitored to improve the quality of care to all those who come in contact with the service provided by the Trusts Clinical Research Facility. The post holder has responsibility for safety as outlined in the hospitals policy and Health and Safety Work Act 1974. To maintain the childs confidentiality at all times. To ensure that the views of consumers are effectively sought, channelled and acted upon.This includes efficient actioning of the complaints procedure in accordance with Trust policies and in conjunction with the Clinical Manager.
To support and assist on the mobile research Unit if needed.
