Job summary
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.
About us
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.
Job description
Job 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?
Job description
Job 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
- 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
- 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
- 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
- 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
- Experience of delivering training to healthcare or research professionals
Personal Qualities
Essential
- 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
- Familiarity with medical terminology
- Proven ability to proactively drive forward change and develop new
Person Specification
Knowledge & Qualifications
Essential
- 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
- 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
- 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
- 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
- Experience of delivering training to healthcare or research professionals
Personal Qualities
Essential
- 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
- Familiarity with medical terminology
- Proven ability to proactively drive forward change and develop new
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
University College London Hospitals NHS Foundation Trust
Address
University College London Hospital
250 Euston Road
London
NW1 2PG
Employer's website
https://www.uclh.nhs.uk (Opens in a new tab)
