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Research Quality Assurance Officer
3 months ago
The post-holder will work with Clinical Leads, Medical Teams, Nursing Teams, Management and Administrative staff within the Trust to ensure compliance with required quality standards.
The post-holder will be required to work across the Trust and with external organisations to ensure that the services meet the required quality measures and will lead service improvement initiatives across the Research Team.
To support the Senior Research Manager in ensuring that quality assurance activities are proportionate to the nature and scope of research activities performed by MYTT.
Lead an internal programme of study monitoring in line with Trust SOP and work closely with Clinical Research Team.To create a monitoring programme to ensure that at least 10% of all hosted clinical trials at MYTT are monitored.
Coordinate the planning, preparation, conduct and follow up of audits to monitor adherence to SOPs, protocols, contracts, the principles of GCP and relevant UK Regulations and provide written feedback of findings to Research Management Team and Research Committee.
Perform system audits across the research infrastructure to ensure that they are efficient and effective, making recommendations for improvements and leading on process improvement projects.
The post holder will work closely with the Research Management Team and Research Committee to ensure the implementation of quality systems across research studies.
Present monitoring and audit outcomes to research management team, Research Committee and other relevant audiences using PowerPoint presentation software and other tools as appropriate.
Advise on actions required after monitoring to improve regulatory compliance and best practice standards.Ensure that vendors and systems are regularly audited and validated in line with inspection requirements. Determine, enforce and document database policies, procedures and standards. The post-holder will manage the local document database to ensure control of all documentation.
Performance Monitoring and Reporting Lead on the development of the local portfolio management system Coordinate the production of regular research performance reports to internal and external audiences.
Including but not limited to the Trust Research Committee, NIHR, DoH and MHRA.Manage the provision of research performance data so that it is reported in a timely manner to the Research Management Team, Research Committee and Trust Board.
Keep an up to date record of research performance activity including recruitment data and lead on the reporting of Trust performance to internal and external audiences including Research Committee, NIHR, Y&H Research Network, DoH, MHRA.
Work closely with the Research Management and Support team, Senior Clinical Trials Assistants and others to ensure all relevant metrics are recorded, and updated.
Work with existing Trust databases, NIHR systems such as Open Data Platform Central Portfolio Management System and Local Portfolio Management System (Edge).
Co-ordinate and Chair the Quality Group meeting and ensure that decisions, learning points and findings from the meeting are disseminated to the MYTT research community at every level in appropriate formats.
Maintaining records and provide regular reports to the Research Director, Research Management team and Research Committee on regulatory compliance of research studies.
Clinical research planning and conduct Support the review of research documentation for MYTT sponsorship approval, undertaking risk assessment and quality check of the research protocol and the associated documents according to the relevant SOPs.
Ensure MYTT sponsored studies are monitored according to local policy and that any training, support, and guidance is provided to the Chief Investigator and study team to ensure ongoing regulatory compliance.
Support the Research Governance Manager to oversee maintenance of a risk-based system for identifying and prioritising clinical research studies and trials requiring audit/monitoring.
Support the Head of Research with the activities relating to preparation for statutory inspections (including MHRA, FDA and HTA).Support the Head of Research to respond to the findings of MHRA, FDA and HTA inspections, taking forward corrective action across the Trust.
Identify and collate areas of risk and escalate findings and enable the Head of Research to report on corrective actions to the Quality Group and Research Committee Prepare presentations and meetings with all staff groups to inform of preparation activities and outcomes of inspections.
To ensure that data is archived and recorded in an appropriate manner in line with current research legislation and that this is continually monitored and adjusted as required.
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