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Quality Assurance Clinical Trials Monitor

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University of Leeds

1mo ago

  • Job
    Full-time
    Junior, Mid & Senior Level
  • Research & Development
  • Leeds

AI generated summary

  • You should have knowledge of UK clinical trial regulations, Good Clinical Practice, monitoring experience, strong communication skills, and the ability to work independently or in a team.
  • You will monitor clinical trials for compliance, lead site visits, perform central monitoring, and manage trial governance activities from the QA office.

Requirements

  • - Working knowledge of UK regulatory and governance requirements relating to clinical trials research
  • - Understanding of Good Clinical Practice standards
  • - Experience in monitoring clinical trials or similar studies
  • - Ability to lead site monitoring visits
  • - Strong communication and interpersonal skills
  • - Capacity to work both independently and as part of a team
  • - Commitment to delivering high-quality support in research governance
  • - Understanding of the Clinical Trial Regulations and UK Policy for Health and Social Care Research
  • - Eligibility for first-time Skilled Worker visa applicants if applicable
  • - Consideration for eligibility under the Global Talent visa for research and academic posts

Responsibilities

  • You will join the team as a Clinical Trials Monitor, responsible for monitoring a portfolio of LTHT and UoL Sponsored studies against Good Clinical Practice standards, the Clinical Trial Regulations and the UK Policy for Health and Social Care Research.
  • This will include leading site monitoring visits within LTHT and performing central monitoring, trial management and wider governance activities from within the QA office.

FAQs

What is the primary location for the Quality Assurance Clinical Trials Monitor role?

The role is based on the university campus, with opportunities for hybrid working arrangements.

Who will I be working with in this role?

You will be part of the established research governance team at the University of Leeds and Leeds Teaching Hospitals NHS Trust, focusing on improving clinical trial research.

What qualifications or knowledge should I have for this role?

Candidates should have a working knowledge of UK regulatory and governance requirements related to clinical trials research.

What are my main responsibilities as a Clinical Trials Monitor?

You will be responsible for monitoring LTHT and UoL Sponsored studies, leading site monitoring visits, performing central monitoring, and conducting trial management and governance activities.

Are there any specific visa requirements for applicants?

Yes, due to Home Office visa requirements, this role may only be suitable for first-time Skilled Worker visa applicants eligible for salary concessions, or under the Global Talent visa for research and academic posts.

What benefits does the position offer?

The position offers 26 days of holiday plus approximately 16 Bank Holidays, generous pension schemes, health and wellbeing benefits, personal development opportunities, and access to on-site childcare and other discounts.

Who should I contact for further queries about the role?

For any queries, you can contact Louise Harris, Quality Assurance Manager (Clinical Trials), via email at L.Brook@leeds.ac.uk.

What is the work schedule like for this position?

The work schedule is flexible, with scope for hybrid arrangements and discussions about flexible working options.

Are there opportunities for professional development in this role?

Yes, you will have access to courses provided by the Organisational Development & Professional Learning team for personal development.

Is this role focused solely on clinical trials, or does it include other research activities?

While the primary focus is on clinical trials, you will also engage in wider governance activities within the QA office.

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University of Leeds

Celebrating the people, the research and life at Leeds

Education
Industry
5001-10,000
Employees
1904
Founded Year

Mission & Purpose

The University of Leeds is an esteemed institution renowned for providing a broad spectrum of academic courses and conducting pioneering research across various disciplines. Their primary goal revolves around nurturing academic excellence, fostering innovation, and nurturing students' growth. The university's fundamental objective lies in delivering quality education, encouraging critical thinking, and advancing knowledge through cutting-edge research, equipping students to excel in their chosen fields and contribute positively to society's progress.

Culture & Values

  • Collaboration

    We work together to achieve our goals and ambitions

  • Compassion

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  • Inclusivity

    We are a community where everyone is welcome and belongs

  • Integrity

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