Research Audit & Assurance Co-ordinator

Job overview

This role is not eligible for visa sponsorship. If it is identified that you require sponsorship to undertake this role your application may be withdrawn

The Research Audit & Assurance Co-ordinator supports the Research Governance Manager and the Head of Research Governance & Innovation, to implement and maintain the research assurance (study set up, monitoring, sponsorship) processes within the Trust. Working as part of the Research Support Team, the post will oversee processes for research governance and quality management across the Trust, to ensure that research cannot commence without all the relevant regulatory approvals in place and that all research activity is delivered to protocol, time and target.

Main duties of the job

• The post holder will support the Trust sponsorship pathway, being the first point of contact for advice and applications to the pathway; supporting the Head of Research Governance & Innovation in implementing and maintaining the process. The post holder will be responsible for conducting high-quality research delivery audits at all sites (including in collaborative partnership) where research is delivered. The role will largely include planning an auditing programme within the Research & Innovation department for the post holder to work on by reviewing all archived and current research studies/trials.

Detailed job description and main responsibilities

This vacancy is only open at this stage to internal employees of the following organisations within the Staffordshire and Stoke-on-Trent Integrated Care System:

• Midlands Partnership University NHS Foundation Trust.
• North Staffordshire Combined Healthcare NHS Trust.
• University Hospitals of North Midlands NHS Trust, inclusive of Black Country Procurement Group and North Midlands and Cheshire Pathology Service.
• Staffordshire and Stoke-on-Trent Integrated Care Board.

Working closely with the Research Managers, the post holder will contribute to the delivery of the Research & Innovation objectives and strategy; and to operational plans to embed research as core business within the Trust.

To be a primary contact for the provision of appropriate advice and support to researchers and research staff on all aspects of research governance and study set-up including the application processes, ethics application process, contracts and NHS indemnity.

• The post holder will support the Trust sponsorship pathway, being the first point of contact for advice and applications to the pathway
• To support the Head of Research Governance & Innovation in implementing and maintaining the sponsorship process, ensuring the pathway is kept in line with guidelines and legislation; updating the pathway paperwork and website accordingly; and supporting researchers through the process
• To maintain and implement the Trust Research Transparency information in line with processes
• To undertake audits on current and archived research delivery studies and clinical trials in accordance with ICH Good Clinical Practice (GCP) and Medicines & Healthcare Products Regulatory Agency (MHRA) standards
• Writing high quality and sensitive audit reports that summarise key findings and make recommendations for improvements to procedures, governance, risk and other delivery processes
• To set up clinical audit tools and checklists in preparation for each audit
• To plan and produce an audit strategy and an annual audit programme
• To maintain and follow up all audits using a progress tracker
• To analyse data, problem solve and have a high attention to detail in order to ensure all aspects of the investigator site file (ISF) are in accordance with necessary regulatory standards (both paper and electronic sites files)
• To undertake regular management audits of processes and systems – EDGE, document completion, filing and storage
• To identify any site issues/problems, and associated root causes, and develop action plans to ensure resolution, including escalation of appropriate issues in a timely manner
• To oversee the Research Support Administrators in assisting researchers and other research staff with queries relating to honorary research agreements and ensure the correct documents are submitted through the Research Passport Scheme
• To work with the local research team and operational managers to collect local information, identify issues that need resolving and ensure continuous process.

Applicant requirements

This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.