Adhering to GCP at all times. Responsible to support existing team and support current portfolio and develop it further and work.....
Adhering to GCP at all times. Responsible to support existing team and support current portfolio and develop it further and work to recruit to time to target. Working closely with Research Manager, R&D Lead, Chief Investigators, Principle Investigators, Local R&D, REC, external stakeholders. CLINICAL: Work autonomously to manage and coordinate existing and new portfolio of clinical research whilst working as part of a multidisciplinary team. Maintaining effective communication with patients, carers and professionals to ensure service delivery. Assist in selecting, screening and organising the patients and/or volunteers suitable for entry into clinical trials/studies when applicable. Ensure team are fully informed trained in all of the trials and play a key role to support informed consent to participate, randomising and allocating treatments as required. Act as a resource and support to patients and their relatives, explaining practical aspects of the trial or study, assisting and supporting local nursing teams. Coordinate the collection of all biological samples required as part of the clinical trial/study and ensure safe and appropriate storage of specimens, in conjunction with Sponsors. Ensure the safe administration of trial drugs, have in-depth knowledge of the legal requirements of a clinical trial sponsor regarding pharmacovigilance and of the Trust pharmacovigilance policy. Report any adverse events and reactions in accordance with this policy and the trial protocol. At all times to ensure clear, accurate records are maintained by the team. Implement and adhere to the principles of Good Clinical Practice (GCP) and ensure that all trials are conducted according to the Medicines for Human Use (Clinical Trial) Regulations 2004 and Amended Regulations 2006 where appropriate. Perform tasks requiring highly developed clinical skills including phlebotomy, cannulation and be able to care for patients in the critical care environment. To oversee the routine maintenance and servicing of clinical equipment MANAGEMENT: To act as clinical supervisor to junior research staff and act as a role model for excellence in clinical research. To represent Guys and St Thomas NHS Foundation Trust as an expert research nurse in external situations, for example national and international conferences, committees etc. To report any adverse incident/near misses in relation to that activity To facilitate and maintain effective communication within the clinical team. To responsibly manage the control of equipment, resources and stock through the adherence of research policies and clinical trials budgets. EDUCATION: Ensure mandatory clinical trials training is undertaken and updated as required. To be responsible for developing and sustaining own knowledge, clinical skills and professional awareness. PROFESSIONAL: You will be accountable for your own professional actions, and be a lead specialist for defined area acting within clearly defined policies/procedures and codes of conduct including the NMC code and Trust policy. To act in accordance with local policies and procedures laid down by Guys and St Thomas NHS Foundation Trust and ensure that all mandatory training for nursing staff within the Trust is attended.To work within the NMC Scope of Professional Practice and Code of Conduct. To undertake Performance Development Review annually to identify organisational and professional objectives and developmental needs.To keep up to date with departmental, Trust, NHS, academic and EU developments for the management of clinical research ensuring timely, effective implementation of changes. To attend courses as deemed relevant, including mandatory training, and to attend meetings and conferences as appropriate.
