Quality Assurance Manager (Clinical Research)

University College London Hospital; London; On-site; GBP 40,000 - 60,000; Full time

Job summary

Une opportunité passionnante se présente pour rejoindre l'équipe d'Assurance Qualité au Bureau de Recherche de l'University College London Hospitals NHS Foundation Trust. Le candidat retenu jouera un rôle clé dans l'établissement d'un système de gestion de la qualité, garantissant la conformité aux exigences réglementaires et aux normes de qualité. Ce poste nécessite des compétences en communication, planification et résolution de problèmes, ainsi qu'une expérience antérieure en recherche clinique.

Benefits

Prêt sans intérêt pour les abonnements de transport

Accès à un soutien indépendant et confidentiel

Remises sur les magasins de détail

Programme de bien-être artistique

Qualifications

• Connaissance approfondie des priorités nationales en matière de recherche et développement.
• Expérience en audit et/ou surveillance des études de recherche.
• Capacité à établir des systèmes de gestion de la qualité.

Responsibilities

• Soutenir les collègues dans le programme d'audit QA.
• Développer des politiques et procédures de recherche.
• Assurer la liaison avec les responsables QA des divisions.

Skills

Communication

Planification

Résolution de problèmes

Gestion de projet

Analyse des données

Education

Diplôme de niveau universitaire

Qualification de niveau Master ou expérience équivalente

Job description

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Job overview

An excellent opportunity has arisen to join the Quality Assurance team at the Joint Research Office (JRO) of University College London (UCL) and University College London Hospitals NHS Foundation Trust (UCLH). UCL and UCLH are two world-class organisations, at the forefront of innovative and ground-breaking clinical research.

The JRO, as part of the Research Directorate, plays a central role in supporting the development and growth of a large, internationally recognised clinical research portfolio. It works with other units and teams across UCLH and UCL to ensure the portfolio is supported by the right expertise and the most effective and efficient systems for meeting regulatory requirements, performance targets and quality and safety standards. The research portfolio covers studies that fall within the scope of the UK Policy Framework for Health and Social Care Research, including Clinical Trials of an Investigational Medicinal Product (CTIMP), observational and interventional research (including UCL student projects).

We are looking to recruit an experienced and highly motivated QA Manager to join the JRO QA Unit. This is an exciting time to join the QA team, as the successful candidate will play a pivotal role in establishing the overarching Quality Management System through the development and implementation of a framework of systems and processes to ensure adherence to relevant research governance, policy and regulatory requirements.

Main duties of the job

The post holder will support colleagues in the JRO and across other units, providing expert advice, leading on the QA audit programme and maintaining oversight of regulatory and compliance matters. The post holder will also support the development of organisational research-related policies and procedures and act as the main liaison for UCLH Divisional QA leads.

The successful candidate will have effective communication, planning and problem-solving skills and the ability to meet the challenges of leading an effective QA service demonstrated by a track record of successful implementation of QA initiatives and championing continuous improvement in quality standards. The successful candidate will preferably have QA experience from working in an NHS, academic or commercial clinical research environment.

Working for our organisation

University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.

We provide first-class acute and specialist services across eight sites:
• University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)
• National Hospital for Neurology and Neurosurgery
• Royal National Throat, Nose and Ear Hospital
• Eastman Dental Hospital
• Royal London Hospital for Integrated Medicine
• University College Hospital Macmillan Cancer Centre
• The Hospital for Tropical Diseases
• University College Hospitals at Westmoreland Street

We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.

At UCLH, we have a real 'One Team' ethos, and our values - safety, kindness, teamwork and improving, are central to the way we work. This is supported by our staff, who voted us as the #1 NHS Acute Trust to work for in the whole of England.

Detailed job description and main responsibilities

For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.

Come and be a part of the best NHS trust in England to work for, according to our staff*

* UCLH top trust to work at in England - In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England - for the third year in a row.

UCLH recognises the benefits of flexible working for staff - To find out more, visit: Flexible working.

To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?

Person specification

Knowledge & Qualifications

Essential criteria

• Educated to degree level or equivalent
• Masters level qualification or equivalent extensive experience
• Specialist knowledge and detailed understanding of national R&D priorities and developments
• Expert knowledge of the UK Policy Framework for H&SC Research, EU Regulations for clinical trials and other legal requirements relating to research.
• Recognised Good Clinical Practice training
• Expert knowledge of the functions and application of audit and monitoring of research studies (sponsorship and host approved)

Experience

Essential criteria

• Relevant and proven experience in auditing and/or monitoring of research studies as a Sponsor and/or Host NHS Trust
• Evidence of maintaining complex data bases
• Experience in compiling and writing Standard Operating Procedures (SOPs)
• Evidence of developing Quality Assurance systems and procedures
• Experience in handling and investigating complex complaints or incidents relating to research delivery and conduct
• Allocation of tasks and projects to others and supervision of outcomes
• Line management or supervision
• Experience of research inspections and audits (external and regulatory authorities)
• Analysing practises and implementing policies on an organisational level to improve outcomes

Desirable criteria

• Evidence of report writing and submission to external parties/regulators
• Dissemination of complex, specialist information to internal and external stakeholders in writing and via presentation
• Formal Presentations at Senior level, demonstrating the ability to engage a wide range of stakeholders

Skills & Abilities

Essential criteria

• Evidence of complex relationship building with senior stakeholders
• Advanced numeracy and problem solving skills
• Experience of working with Microsoft, Word, Excel and PowerPoint to a level to generate own work
• Experience of using databases and of data analytical skills including the analysis of multiple sources of information to ensure compliance with targets and regulatory requirements
• Project management including independently initiating and delivery of projects to meet targets
• Ability to prioritise conflicting and changing demands
• Ability to work independently and on own initiative
• Experience of working with incident reporting systems (DATIX or equivalent)

Desirable criteria

• Experience of delivering training to healthcare or research professionals

Personal Qualities

Essential criteria

• Excellent communication skills, written and verbal
• Strong desire to share best practice and find improvements in service delivery
• Proven ability to develop effective working relationships with staff at all levels

Other requirements

Essential criteria

• Familiarity with medical terminology
• Proven ability to proactively drive forward change and develop new

At UCLH, we have a real 'One Team' ethos, and our values - safety, kindness, teamwork and improving, are central to the way we work. This is supported by our staff, who voted us as the #1 NHS Acute Trust to work for in the whole of England.

At UCLH we take equality of opportunity seriously and are committed to being a diverse and inclusive employer, with a culture that creates a real sense of belonging and trust. It is our fundamental aim, to recruit, retain and promote a diverse mix of people who are representative of our local communities. Applications are encouraged from candidates of all backgrounds, cultures, and perspectives to support our world class research, innovation and creativity.

UCLH recognises the benefits of flexible working for staff and has a dedicated policy which allows staff to apply for flexible working right from the beginning of employment. For more information please go to: https://www.uclh.nhs.uk/work-with-us/why-choose-uclh/flexible-working.

We offer our permanent staff an interest free season ticket loan for travel, all our staff have access to free independent and confidential support, large retail discounts, a staff discount platform, cycle to work scheme and on-site accommodation to name a few.

Additionally, UCLH Arts and Heritage's staff wellbeing programme, Creative Comfort, offers a variety of ways to engage with the arts as a member of UCLH staff. You can try out the weekly choir, weekly art club and join the Culture Club for exclusive access to free and discounted tickets for opera, exhibitions, theatre and more.

We recognise, reward and thank colleagues by nominating them for our annual Celebrating Excellence Awards, which are funded by UCLH Charity.

We are also members of www.mytrustbenefits.co.uk/ which offers discounts on high street retail stores, offers on travel deals, and also to take advantage of cash back schemes.

This vacancy may close before the current listed closing date. You are advised not to delay submitting your completed application.

Please note that all correspondence regarding your application will be via email. The emails will be sent to you via TRAC.jobs and not via NHS Jobs, we encourage you to check your inbox regularly.

Please note that if you are at present in a training position on the 2016 new junior doctor's contract and are applying for a Trust doctor role your salary will not be pay protected.

You will be placed on the appropriate point of the Trust Doctor pay scale based on your previous experience.

Please note that if you have not heard from us within 3 weeks of the closing date of the advert to assume that you have not been shortlisted on this occasion.

The Trust uses electronic new starter forms on Trac to collect personal details. Information collected is securely stored and used to set up the employee record on the ESR HR system.

Employer certification / accreditation badges

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.

Documents to download

• Job Description (PDF, 1.3MB)
• Functional Requirements (PDF, 262.3KB)
• UCLH Values (PDF, 860.9KB)