Research Audit & Assurance Co-ordinator in Stafford

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.

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.

Person specification

Qualifications

Essential criteria

• Educated to degree level or portfolio of evidence of equivalent experience

Desirable criteria

• Post-graduate qualifications or evidence of CPD

Qualifications

Essential criteria

• Advanced knowledge and experience of GCP, IRAS, HRA

Experience

Essential criteria

• Knowledge and experience of research or clinical study management.

Desirable criteria

• Experience of NHS research delivery

Experience

Essential criteria

• Experience and expertise of processes involving research finance, NCVR, ETCs and commercial study contracts and invoicing

Desirable criteria

• Extensive experience in processing commercial trial contracts and finance

Experience

Essential criteria

• Experience of information management e.g. inputting/extracting data from databases, electronic and paper based filing.
• Experience of working in a research, service evaluation or audit environment (NHS, university or industry)

Desirable criteria

• Experience and expert knowledge of EDGE, REDCAP and power BI
• Extensive experience of NHS research

Skills

Essential criteria

• Demonstrable expertise in Microsoft Office including Excel

Desirable criteria

• EDCL qualification

Skills

Essential criteria

• Excellent communication skills, including report writing for external audiences

Desirable criteria

• Ability to administer complex linked databases for research, evaluation, clinical audit and clinical outcomes

Visa eligibility notice:

The UK Home Office has imposed an emergency brake on specific visa routes.

• Skilled Worker visas cannot currently be issued to Afghan nationals.
• Study visas cannot currently be issued to nationals of Afghanistan, Cameroon, Myanmar or Sudan.

  As a result, we are unable to progress applications requiring sponsorship under these routes.

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.

Documents to download

• JD ( PDF , 720.3 KB )
• Benefits Booklet ( PDF , 1.1 MB )