The Research Assistant Practitioner will provide clinical and administrative support to clinical research teams, ensuring the safe conduct of research in accordance with the regulatory and legal frameworks relating to the planning, undertaking, and closure of research studies, providing assurance that the rights, safety, and well-being of trial participants are protected. The post holder will be supported through a comprehensive training/competency package as appropriate to the job role and will assist in the identification, recruitment, and management of participants into a portfolio of research studies including but not restricted to commercial and non-commercial clinical trials. Having completed all relevant competencies and under the supervision of registered nursing staff, they will also be responsible for the coordination and management of a portfolio of research studies that do not involve administration of medicines and contribute to the delivery of clinical trials within the bounds of their clinical practice. The job holder may be required to carry out other similar or related duties which do not fall within the work outlined in the description which may reasonably be required to deliver a comprehensive research service to our patients. The Line Manager, in consultation with the post holder, will undertake any review. Please note that sponsorship is not eligible for this post. Clinical Provide appropriate information to patients and their carers participating in studies. Arrange patient assessments and visits as appropriate to relevant study protocol. Assist the research team in the preparation and conduct of the clinic visits for patients enrolled in research study. Under supervision or after appropriate training, carry out clinical procedures including but not limited to vital sign measurement, ECG acquisition, phlebotomy and cannulation, height, weight blood pressure measurements. Report all findings from clinical procedures to research team and accurately document as advised by the team in appropriate research files, logs, and databases and patient records. After appropriate training and assessment of competence, process blood, urine, and other samples according to protocols such as preparing serum separation using centrifuge and pipetting. Preparing for ambient or frozen storage and shipment as directed. Arrange couriers for safe and timely transport of all clinical samples. Attend multi-disciplinary meetings to support the team with patient identification and recruitment. Research Teams This summary contains the core responsibilities as listed, allowing for a core job description to be used across Specialties enabling standardisation of the responsibilities. The post holder will be employed by the Research and Development Department (R&D) to work flexibly across several research speciality teams as service requirements dictate. They will contribute to the provision of a clinical research service based normally at the location of the employing organisation (UHCW NHS Trust); however, travel to other sites may be required as per study requirements or set out under contractual agreements for the delivery of a local cross-cutting clinical research service. Support Research Nurses and Physicians by assisting in the planning and conduct of all types of research studies. Adhere to trial protocols and work in accordance with ICH GCP and Trust Standard Operating Procedures. Manage and co-ordinate own portfolio of uncomplicated studies, not requiring qualified medical/nursing intervention in accordance with the relevant Local, National and International guidelines. Use databases to access patient groups to improve patient opportunity and recruitment to trials. Identify/screen patients for studies and register/enroll patients into these studies, ensuring informed consent is in place. After appropriate training and competence assessment, obtain written informed consent for allocated non-interventional research studies as delegated by the Principal Investigator. Coordinate and manage a portfolio of non-interventional research studies in line with protocol ethics approvals. Coordinate the follow-up of an identified caseload of trial patients with minimal supervision. Day-to-day maintenance of patient records whilst the trial is in progress, data entry onto electronic or paper-based case records forms. Assist in the preparation of and participate in monitoring visits, and respond to data queries. Ensure serious adverse events are reported and acted upon as required by the protocol in liaison with a research nurse and/or Principal Investigator. Facilitate the secure filing and storage of study documentation and maintain specific site files in accordance with ICH-GCP and research Governance. Ensure clear, concise, and accurate records are kept for research projects in accordance with all regulatory requirements including the data protection act. Maintain accurate records of study recruitment as per local procedure and status of studies providing regular updates. When appropriate, enter patients onto hospital alert systems. Utilise information and IT systems to secure accurate and timely patient data. Education, Training and Development Keep up to date with departmental Trust, NHS and EU developments for the implementation of clinical research. Undertake any training and assessment of competency required for the role. Attend courses, meetings, and conferences as deemed relevant and appropriate. Responsible for developing and sustaining own knowledge, clinical skills, and professional awareness. Keep up to date with GCP training, in line with study/sponsor requirements and Trust Operating Procedures. Other Update and maintain mandatory and statutory training as required by the Trust. Be flexible in approach with working times and workload management. Assist the research Nurses in orientation of new staff to the department. Observes confidentiality of patient information at all times in accordance with the Data Protection Act.