Clinical Studies Assistant/Research nurse (Maternity cover)

Research Context Demonstrate a comprehensive understanding of the portfolio of studies taking place in the Trust. Demonstrate a practical understanding of how the principles of Good Clinical Practice (GCP) are implemented using everyday examples of their working practice. Be able to discusses their individual contribution to delivering research in the NHS and understand the role of their colleagues. Be able to identify different study types (e.g., interventional, observation) and design (e.g., randomised, double-blind) and explain what these terms mean. Monitor compliance with governance requirements and promptly report any non-compliance issues to line manager. Study set-up Establish trial site files compliant with research governance and GCP requirements. Assists in the organisation of trial documentation for study set-up. Contribute to feasibility assessments under supervision. Demonstrate a broad awareness of the approvals required to conduct research in the NHS studies and the processes by which these approvals are obtained. Completes the delegation log for a new trial & demonstrates understanding of delegated duties. Assist in identifying suitable clinical services, wards, or departments for participant recruitment. Under supervision, collaborate with clinical services during the study set-up phase. As required, attend site initiation visits with the Principal Investigator, research team and clinical staff to ensure effective study launch and protocol understanding. Study delivery Liaise with clinical teams to promote research studies and ensure appropriate referrals and recruitment of participants. Identify, screen, and recruit participants in line with protocol-defined inclusion and exclusion criteria, adhering to national and local approvals. Clearly explain studies to service users, address their questions, and obtain informed consent in accordance with GCP principles. Provide comprehensive information about studies to service users, and where appropriate extending this information to families, and treating clinicians to ensure informed decision-making. Where appropriate apply capacity assessment at consent and baseline visit. Proactively seeks documentation to confirm informed consent has been provided by the participant; and Identifies errors/concerns in documents. Undertakes collection of biological samples (including blood & phlebotomy) in line with local & national regulations Facilitate delivery of baseline measures in line with the study protocol e.g. psychological assessments. Contribute to the collection and reporting of local recruitment data by maintaining updated screening and recruitment logs as required. Regularly monitor and report study recruitment progress, identify areas of low recruitment, and work with line manager to implement strategies for improvement. Contribute to the development of policies and standard operating procedures (SOPs) to support adherence to protocols. Data Management Collect, collate, and manage research data in strict adherence to study protocols, ensuring accuracy and completeness. Establish and/or maintain in-house and sponsor documentation systems and accurate study contacts. Creates and maintains research files according to standard operating procedures (SOPs); demonstrates an ability to manage version control of study documents. Maintain meticulous and accurate patient records, ensuring all relevant study information is documented in medical notes and source documentation; identify and seek to correct incomplete, inaccurate, or misleading documentation or data entry. Undertake the accurate and complete collection of data, and insertion of data into case report forms (CRFs) and other study-related documentation; identify errors and inconsistencies between CRFs and source data and seek to resolve these. Ensure that all data collection and storage meet the requirements of study protocols, research governance, and data protection legislation. Facilitate accurate and timely recording of patient recruitment data using the EDGE Data Entry System. Has a robust understanding of what constitutes a data breach/ confidentiality breach and raises concerns when processes to ensure confidentiality are not adhered to. Prepare documents and facilities for monitoring visits and work with the study monitor during visit; respond to auditing and monitoring recommendations. Contributes to study closure and preparation of documents for archiving, liaising with the sponsor and R&I department. Patient Care Articulates their own responsibilities and recognises the boundary of their own role and when to refer to others. Raise concerns and report instances of suspected protocol deviation. Identify and escalate patient risks to the appropriate care team during study visits, ensuring timely intervention. Record and report incidents of harm or near misses in line with the Trusts incident reporting policies, including timely and appropriate referral. Prepares initial and follow-up adverse event reports in liaison with clinical staff.