Are you experienced in clinical trials administration of internally sponsored studies and are seeking to develop specialist skills and knowledge in sponsorship governance? Do you have excellent organisation and communication skills. Are you detail orientated and able to manage competing deadlines and priorities?

We are recruiting a Sponsorship Governance Coordinator to join the Research Office within the Research & Innovation (R& I) service at Manchester University NHS Foundation Trust. The successful candidate will provide expert advice during the setup of Trust sponsored research and oversight of existing research.

Main duties of the job

As a key member of the team, you will ensure the Trust carries out its responsibilities as sponsor for all Trust Sponsored research studies. You will expert advice and regulatory support to researchers from grant application, through sponsorship and regulatory approval, initiation at sites, study conduct and close-down ensuring studies meet regulatory requirements and other obligations as Sponsor. The study portfolio will include CTIMPs, device trials, surgical and interventional trials, basic science studies involving procedures with human participants, observational studies, qualitative research and studies working with tissue or data.

You will act as the sponsor representative for Trust studies, ensuring research studies and their associated documentation is of consistently high standard, meets Trust requirements and that the studies are managed well by the research team. This will involve creating a performance management framework, monitoring that criteria, and escalating issues to senior management within the R& I.

You will be required to work autonomously, managing your day-to-day workload and prioritising as needed.

About us

MFT is England's largest NHS Trust with a turnover of �2.5bn & is on a different scale than most other NHS Trusts. We're creating an exceptional integrated health & social care system for the 1 million patients who rely on our services every year.

Bringing together 10 hospitals & community services from across Manchester, Trafford & beyond, we champion collaborative working & transformation, encouraging our 28,000 workforce to pursue their most ambitious goals. We set standards that other Trusts seek to emulate so you'll benefit from a scale of opportunity that is nothing short of extraordinary.

We've also created a digitally enabled organisation to improve clinical quality, patient & staff experience, operational effectiveness & driving research and innovation through the introduction of Hive our brand-new Electronic Patient Record system which we've launched in September 2022.

We're proud to be a major academic Research Centre & Education provider, providing you with a robust infrastructure to encourage and facilitate high-quality research programmes. What's more, we're excited to be embarking on our new Green Plan which will set out how MFT continues to play its part in making healthcare more sustainable.

At MFT, we create and foster a culture of inclusion and belonging, provide equal opportunities for career development that are fair, open and transparent, protecting your health and wellbeing and shaping the future of our organisation together.

Job description

Job responsibilities

To find out more about the key responsibilities and the specific skills and experience youll need, take a look at the Job Description & Person Specification attachments under the Supporting Documents heading. So that youre even more equipped to make an informed decision to apply to us, youll need to take time to read the Candidate Essentials Guide that sits with the Job Description and Person Specification. This document provides you with details about the Trust, our benefits and outlines how we care for you as you care for others. Most importantly, it also contains critical information youll need to be aware of before you submit an application form.

COVID-19 vaccination remains the best way to protect yourself, your family, your colleagues and of course patients from the virus when working in our healthcare settings. Whilst COVID-19 vaccination is not currently a condition of employment, we do encourage our staff to get vaccinated. If you are unvaccinated, there is helpful advice and information available by searching on the NHS England website where you can also find out more about how to access the vaccination.

Diversity Matters

MFT is committed to promoting equality of opportunity, celebrating and valuing diversity and eliminating any form of unlawful discrimination across our workforce, ensuring our people are truly representative of the communities we serve. All individuals regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex and sexual orientation are encouraged to apply for this post. As an inclusive employer, we are here to support you. If you have any special requirements to help you with your application, email our team atresourcing@mft.nhs.uk.

Person Specification

Qualifications

Essential

• oEducated to Post Graduate Degree or Equivalent specialised professional knowledge

Desirable

• oEvidence of Continuing Professional Development

Knowledge

Essential

• oComprehensive knowledge of research sponsorship responsibilities
• oComprehensive knowledge and understanding of standards and legislation that govern research practice in the NHS
• oComprehensive knowledge and understanding of NHS research governance processes, including amendments

Desirable

• oKnowledge of quantitative and qualitative research methodologies
• oUnderstanding of clinical trial protocol requirements
• oUnderstanding of study data management systems

Training and Experience

Essential

• oExperience in completing an IRAS application, including submission to the HRA
• oExperience developing research study related documentation, e.g. PIS, CF, CRF
• oGood Clinical Practice training

Desirable

• oExperience acting as sponsor representative or research experience
• oExperience within a teaching hospital setting
• oExperience of writing standard operating procedures

Skills and Abilities

Essential

• oGood, well-written communication style
• oAbility to use judgement and work independently
• oGood organisational and time management skills

Desirable

• oAbility to use own initiative where appropriate and be proactive in approach to work

Employer details

Employer name

Manchester University NHS Foundation Trust

Address

Oxford Road Campus

Manchester

M13 9WU

Any attachments will be accessible after you click to apply.

349-RES-5627505