Job overview Are you an experienced and dynamic clinical research nurse who can confidently lead our research team and manage our growing portfolio of Vaccine and Trials Research? Then this role might be for you! You will be joining an enthusiastic, friendly, and motivated multidisciplinary team in a dynamic teaching hospital in central London working across the multiple areas to deliver to a high standard. The research portfolio consists of trials looking at the safety and efficacy of treatments, prophylactics and vaccines for COVID and other infection groups. You will work closely with the R&D Lead, Principal Investigators and clinical staff to ensure a safe and high-quality level of care for our patients and their families or carers. Applicants must be a registered adult nurse with evidence of continuing professional development. You should have good experience in working within the NHS, a strong clinical background and a desire and willingness to learn & develop others. Candidates must demonstrate excellent communication and interpersonal skills, and have the ability and initiative to work independently and manage a patient caseload across a variety of research studies. Main duties of the job Assess, plan, implement, and evaluate expert research nursing care and provide support to patients attending the Department who have been or have the potential to be recruited onto a clinical trial programme. The research nurse will play a key role in ensuring that any research undertaken within the department safeguards the well-being of the patients and is conducted according to Good Clinical Practice (GCP) and the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006. In conjunction with the other members of the Vaccine and Trials team, facilitate the production of good quality of research. The research nurse will facilitate and aid in the recruitment of patients to ensure high quality clinical studies and trials which will require the nurse to work flexibly across the disciplines to ensure the successful working of the clinical research projects they are assigned to. They will also act as a patient advocate providing support and assistance as required and assist in the co-ordination and management of a portfolio of clinical research studies. The post holder will take responsibility for the safe administration of experimental therapies, and for monitoring the expected and unexpected side effects of drugs and other treatment modalities used in these trials. Working for your organisation The Vaccine and Trials research team hosts a portfolio of clinical trials assessing the safety and efficacy of COVID-19 vaccines, treatments and prophylactics. The team is based within the St. Thomas’ hospital clinical research facility and comprises of doctors, research nurses, clinical research practitioners, laboratory workers and administrators. You will complete a range of tasks across our varied portfolio of clinical trials. Individual responsibilities are allocated each week through a rota. The team work in COVID and other infectious disease positive areas across both hospital sites as well as in the community on occasion. We will provide a comprehensive induction programme and ensure that all staff have tailored, individual personal development plans with support for further training. Opportunities for developing new research/clinical skills are available and actively encouraged. Detailed job description and main responsibilities Clinical • Carry out planned care required by the clinical trials protocol for a group of volunteers without direct supervision • Ensure the assessment, planning, implementation and evaluation of evidence based, individualised patient/volunteer care • Responsible for recruiting to, and following up, patients within studies. This includes both randomised clinical trials and other high quality clinical studies. The role will involve working closely with multidisciplinary clinical team • Act as a patient advocate enabling patients to make informed choices concerning their involvement in the clinical trials and ensuring advice and information is provided • Ensure there is sufficient skill mix of staff for patient safety during clinical trials and ensuring that they are carried out within the Trust and Centre's policies and clinical trial protocol • Assist in clinical trials including venepuncture and cannulation of volunteers when necessary ensuring that they are carried out within the Trust’s policies, research governance, Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) Data Protection Act and Human Tissue Act • Undertake clinical tasks such as phlebotomy, analysis of blood specimens, drug administration and clinical observation etc • Assist and advise staff, both registered and unregistered in the delivery of care to the volunteer • Ensure that written informed consent has always been obtained for any treatment provided for, or any sample or data taken from a Volunteer which will form part of a research study, in accordance with the Trust research governance arrangements and Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) • Have responsibility for the correct administration and custody of medicines according to Trust policy • Maintain all data and case report forms relating to clinical trials in accordance with the Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) and the UK Policy Framework • Report any deviation from normal practice to senior staff and implement agreed changes in care programme • Deal with concerns raised by volunteers and visitors in a proactive manner and take remedial action as necessary • Act as the volunteers advocate Administration • Plan, organise and deploy staff according to ability and workload in order to meet volunteer needs • Ensure that nursing practices comply with Trust policies and procedures • Communicate effectively at all times and maintain a harmonious working environment • Maintain a safe environment in accordance with the Health and Safety at Work Act • Assist the Nurse Manager in managing incidents, accidents and complaints in accordance with Trust policies and procedures • Assist in ensuring the availability of resources for volunteer care • Ensure equipment is in good working order, and report appropriately when defective • Participate in audits, e.g. those undertaken by the Medicines and Health Care Products Regulatory Authority (MHRA) nursing audits and clinical benchmarking exercises and suggest any change to improve standards • Ensure the economical use of resources • Contribute to the overall control of the ward or departmental budget and identify areas where cost improvements can be made • Ensure the safe custody of volunteers property in accordance with Trust policies • Actively participate in and support the development of the clinical research facility • Promote and participate in the implementation of policies within the Centre and to ensure compliance with Trust, Government and EU Directives • Maintain accurate documentation in clinical trial documents and patient notes • Ensure that clinical trials are effectively archived as required • Assist in the process of gaining local regulatory committee approval (ethics and R&D approval) Education and Training • Assist in the education and support of health care professionals to enable them to care for clinical trial patients and recruit to clinical trials where appropriate • Maintain an up to date knowledge of research related topics particularly related to clinical trials • Attend local and national meetings as appropriate and as agreed with the local coordinating centre • Attend regular update sessions at GSTT including the Clinical Research Nurse and Midwife Forum • Assess the needs of volunteers, relatives and carers and provide them with information as requested • Educate and counsel volunteers, family and those who volunteer for clinical trials before, during and after clinical studies and investigations • Assist the Charge Nurse in orientating all new staff and students to the ward or department • Provide teaching and development to the nursing team and students helping them to achieve their learning outcomes • Act as a role model, mentor and preceptor to the nursing team Other • Understand and adhere to Trust policies and procedures • To maintain patient confidentiality and standards of Good Clinical Practice (GCP) at all times • Maintain NMC registration This advert closes on Sunday 28 Apr 2024