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 If it is identified that you require sponsorship to undertake this role your application may be withdrawn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.
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.
By joining Team MPFT, you will be helping your communities and in return for this, we will support you by;
Supporting your career development and progression
Excellent NHS Pension scheme
Generous maternity, paternity and adoption leave
Options for flexible working
Up to 27 days annual leave (increasing with service up to 33 days) and the opportunity to purchase additional leave
Extensive Health and Wellbeing support and resources
If you work in our community teams, we pay for your time travelling between patients
Lease car if you complete more than 500 business miles per annum, fully insured and maintained (including tyres), mileage paid at lease car rate
Salary sacrifice car - fully insured and maintained (including tyres), your gross pay is reduced by the cost of the vehicle before tax, NI and pension deductions are calculated, mileage paid at business rates
Salary sacrifice bikes up to £2k
Free car parking at all trust sites
Free flu vaccinations every year
Citizens Advice support linked with a Hardship Fund for one off additional support up to £250 (if the criteria is met)
And more. We are proud to be a diverse and inclusive organisation and there is a choice of staff networks that help you meet like-minded people.
Please note, we may be required to close this vacancy early if we receive a high volume of applications
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.
1. The post holder will support the Trust sponsorship pathway, being the first point of contact for advice and applications to the pathway
2. 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
3. To maintain and implement the Trust Research Transparency information in line with processes
4. 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
5. Writing high quality and sensitive audit reports that summarise key findings and make recommendations for improvements to procedures, governance, risk and other delivery processes
6. To set up clinical audit tools and checklists in preparation for each audit
7. To plan and produce an audit strategy and an annual audit programme
8. To maintain and follow up all audits using a progress tracker
9. 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)
10. To undertake regular management audits of processes and systems – EDGE, document completion, filing and storage
11. 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
12. 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
13. To work with the local research team and operational managers to collect local information, identify issues that need resolving and ensure continuous process.
