Job Description The post holder will support the development of high-quality clinical research in accordance with legislative and.....
Job Description The post holder will support the development of high-quality clinical research in accordance with legislative and regulatory requirements and the Universitys research governance processes. They will assist the Head of Research, Ethics, Governance and Compliance in providing assurance to key stakeholders that the protection and promotion of the interests of patients and the public is a fundamental part of university health and social care research. Main purpose of the job: The Clinical Research Governance Manager will be responsible for supporting researchers in setting up effective projects and for overseeing ongoing studies, and for ensuring compliance with regulatory requirements and Good Clinical Practice. They will provide expert support for researchers on obtaining the appropriate authorisations and will provide an effective link between external agencies, stakeholders, research teams and relevant University professional services staff. Main duties and accountabilities: Adhere to the requirements of the UK Policy Framework for Health and Social Care Research, Good Clinical Practice (GCP), the Medicines for Human Use (Clinical Trials) Regulations , Human Tissue Act and other guidance/requirements relating to research and University policies as appropriate. Support the University and its researchers in obtaining and complying with relevant regulatory approvals for clinical research Maintain ongoing knowledge of external stakeholder expectations for high quality clinical research Providing expert guidance and advice on appropriate internal and external routes for research ethics review of clinical research Participate in the assessment of new clinical trials (including CTIMP and regulated Medical Device trials), health and social care research applications for sponsorship approval and for ongoing study amendments. Provide, develop and review complex information (e.g. approvals, contract/agreement information, risk assessments) and work with researchers to ensure that all study documentation is produced to an acceptable standard. Ensure the efficient and timely processing of clinical trials, health and social care studies to final approval by providing researchers with the relevant information on the requirements for obtaining relevant approvals and actively supporting researchers with producing study documentation and applications. Develop and improve processes for agreeing sponsorship, working with the Head of Research Ethics and Governance and the team to ensure ongoing proportionate and pragmatic sponsorship oversight mechanisms. Act as the Sponsor Representative for key HRA processes Establish and implement standard operating procedures (SOPs) as necessary to meet regulatory requirements and Good Clinical Practice standards. Consult with relevant CTU and NHS Trust Quality Assurance (QA) colleagues to ensure that SOPs are fit for purpose and meet current regulations and take responsibility for maintaining an appropriate document control system. Develop monitoring plans and undertake systematic study initiation, monitoring, audit and close out visits as necessary for clinical trials (including CTIMP and Medical Device trials) and higher risk studies, according to the monitoring plans. Ensure that breach and adverse event reporting is carried out where required and that appropriate records and report documents are completed. Assist the Head of Research Ethics, Governance and Compliance in investigations of breaches, adverse events and complaints as required and lead on the monitoring of corrective and preventative actions. Take responsibility for preparation for inspections conducted by MHRA and provide assistance for other regulatory inspections as required. Maintain and develop knowledge of the relevant IT systems (e.g. Integrated Research Application System (IRAS), regulatory application systems), research governance and applicable regulations to ensure that instruction and information provided to researchers is accurate. Proactively maintain excellent knowledge of regulations, guidance and best practice relating to clinical research, including Clinical Trial regulations, GCP, data protection regulations and ethical guidelines and be committed to increasing knowledge by participating in CPD, networking with counterparts in HE, NHS and private sector Contribute to process and policy developments across the wider Research Ethics and Governance portfolio. Disseminate and implement these developments as appropriate. Maintain accurate records on projects, updating them in a timely manner, requesting updated information and missing/incorrect information as required. Take responsibility for developing or updating record keeping systems for clinical research as required. Take responsibility for advising on the accurate maintenance of Sponsor Trial Master Files and provide guidance for researchers on structure, maintenance and version control for Trial Master Files, Investigator Site Files and other records as required. Generate reports and letters as required. Support the Head of Research Ethics & Governance in the production of reports and plans. Ensure that information is regularly updated on the Universitys website, SharePoint and Research Toolkit. Facilitate and provide training for trial staff, researchers, students and others as required. Develop and maintain good working relationships with University staff at all levels and with relevant staff from external organisations. Attend meetings within the University and with external organisations as required. Other tasks and activities as required by the Head of Research Ethics and Governance, including provision of cover for other members of the Research Ethics and Governance Team as required.
