Clinical Research Nurse

• CLINICAL RESPONSIBILITIES Work autonomously within professional practice guidelines to manage a caseload of Haematology trial patients, ensuring a duty of care and providing support to patients and their families. Work in accordance with the Research Governance Framework, EU clinical trial requirements and ICH Good Clinical Practice (GCP), ensuring trial protocols are adhered to at all times. Identify patients suitable for entry into Phase 1 - 3 clinical trials by attending Haematology clinics, screening medical notes, reviewing consultant referrals, and participating in Multidisciplinary Team (MDT) meetings. Participate in the informed consent process acting as a resource and support to patients and their families ensuring consent is appropriately obtained and documented. Co-ordinate the research patient pathway from screening through to trial closure, supporting trial set-up activities (e.g. documents collection, trials prompts, patient pathway) in collaboration with the set-up team where required. Administer SACT (Systemic Anti-Cancer Therapy) safely to trial patients and monitor for side effects. Ensures that adequate precautions are taken to minimise the risk of cross-infection in relation to the safe disposal of body fluids including blood products in line with Trust policy. Support delivery of trial treatments in collaboration with local nursing teams (including investigational medicinal products and systemic anti-cancer therapies), and monitor, document and report adverse events/side effects in accordance with the protocol. Maintain accurate, contemporaneous patient records and ensure all relevant information is documented in the patients medical and nursing notes. Complete trial documentation accurately, including Case Report Forms (CRFs), and support the collection, coordination and computerisation of data generated from clinical trials. Keep up to date with current practices for cannulation, phlebotomy, care of patients with Central Venous Access lines and handling and administration for cytotoxic chemotherapy. Act as a role model for excellence in haematology-based research. Portfolio Management and Development Assist with review of trial protocols and highlight practical, risk and resource implications to the Team Lead and relevant colleagues. Liaise with Clinical Trial Set-Up staff to support site set-up activities and contribute to feasibility discussions by highlighting patient pathway issues and potential mitigations to maintain patient safety. Support submissions and ongoing study administration as required (e.g. R&D documentation where applicable), and process amendments, ensuring information is disseminated to relevant departments. Work closely with the medical team and sponsor contacts to support coordination of on-study treatment and follow-up in line with protocol schedules. Contribute to accrual/activity reporting and provide information to support invoice generation where appropriate. Build effective working relationships across departments to support smooth trial delivery and a positive working environment. Provide education/updates to relevant clinical teams about the local portfolio and study requirements where appropriate. Participate in sharing research outputs (e.g. presentations of research activity/findings within the Trust and relevant networks) in line with service needs. Manage clinical incidents appropriately and promptly escalate/report incidents to the Research Team Leader in line with Trust processes. Maintain dialogue with the Research Team Leader regarding progress, workload and issues, attend team handover meetings, and provide cross-cover for colleagues during annual leave, study leave and sickness as required.To report to the Research Team Leader any clinical incidences Maintain a dialogue of progress with the Research Team Leader Attend weekly team handover meetings Provide cover when necessary for annual leave, study leave, sick leave. Professional Development and Leadership Attend the training programmes and other relevant education and training days as agreed in your development plan. Attend investigator meetings and conferences when required. Take responsibility for maintaining professional registration and ongoing development in research practice and clinical care. Represent the research team at local and national forums Contribute to service development and quality improvement within the Haematology Research Team/OHCT service. Mentor and provide day-to-day support and guidance to less experienced colleagues/students as appropriate to their role and competence (without formal line management responsibility). Participate in clinical supervision in accordance with the NMC guidelines. Work in line with Trust policies including confidentiality/information governance, infection control, risk management and health & safety requirements Job description Job responsibilities • CLINICAL RESPONSIBILITIES Work autonomously within professional practice guidelines to manage a caseload of Haematology trial patients, ensuring a duty of care and providing support to patients and their families. Work in accordance with the Research Governance Framework, EU clinical trial requirements and ICH Good Clinical Practice (GCP), ensuring trial protocols are adhered to at all times. Identify patients suitable for entry into Phase 1 - 3 clinical trials by attending Haematology clinics, screening medical notes, reviewing consultant referrals, and participating in Multidisciplinary Team (MDT) meetings. Participate in the informed consent process acting as a resource and support to patients and their families ensuring consent is appropriately obtained and documented. Co-ordinate the research patient pathway from screening through to trial closure, supporting trial set-up activities (e.g. documents collection, trials prompts, patient pathway) in collaboration with the set-up team where required. Administer SACT (Systemic Anti-Cancer Therapy) safely to trial patients and monitor for side effects. Ensures that adequate precautions are taken to minimise the risk of cross-infection in relation to the safe disposal of body fluids including blood products in line with Trust policy. Support delivery of trial treatments in collaboration with local nursing teams (including investigational medicinal products and systemic anti-cancer therapies), and monitor, document and report adverse events/side effects in accordance with the protocol. Maintain accurate, contemporaneous patient records and ensure all relevant information is documented in the patients medical and nursing notes. Complete trial documentation accurately, including Case Report Forms (CRFs), and support the collection, coordination and computerisation of data generated from clinical trials. Keep up to date with current practices for cannulation, phlebotomy, care of patients with Central Venous Access lines and handling and administration for cytotoxic chemotherapy. Act as a role model for excellence in haematology-based research. Portfolio Management and Development Assist with review of trial protocols and highlight practical, risk and resource implications to the Team Lead and relevant colleagues. Liaise with Clinical Trial Set-Up staff to support site set-up activities and contribute to feasibility discussions by highlighting patient pathway issues and potential mitigations to maintain patient safety. Support submissions and ongoing study administration as required (e.g. R&D documentation where applicable), and process amendments, ensuring information is disseminated to relevant departments. Work closely with the medical team and sponsor contacts to support coordination of on-study treatment and follow-up in line with protocol schedules. Contribute to accrual/activity reporting and provide information to support invoice generation where appropriate. Build effective working relationships across departments to support smooth trial delivery and a positive working environment. Provide education/updates to relevant clinical teams about the local portfolio and study requirements where appropriate. Participate in sharing research outputs (e.g. presentations of research activity/findings within the Trust and relevant networks) in line with service needs. Manage clinical incidents appropriately and promptly escalate/report incidents to the Research Team Leader in line with Trust processes. Maintain dialogue with the Research Team Leader regarding progress, workload and issues, attend team handover meetings, and provide cross-cover for colleagues during annual leave, study leave and sickness as required.To report to the Research Team Leader any clinical incidences Maintain a dialogue of progress with the Research Team Leader Attend weekly team handover meetings Provide cover when necessary for annual leave, study leave, sick leave. Professional Development and Leadership Attend the training programmes and other relevant education and training days as agreed in your development plan. Attend investigator meetings and conferences when required. Take responsibility for maintaining professional registration and ongoing development in research practice and clinical care. Represent the research team at local and national forums Contribute to service development and quality improvement within the Haematology Research Team/OHCT service. Mentor and provide day-to-day support and guidance to less experienced colleagues/students as appropriate to their role and competence (without formal line management responsibility). Participate in clinical supervision in accordance with the NMC guidelines. Work in line with Trust policies including confidentiality/information governance, infection control, risk management and health & safety requirements