Job summary
CUH are seeking an individual to fulfil the role of HTA Compliance, Governance and Quality lead. You will have experience of managing compliance and quality and should also have experience of working with the Human Tissue Authority.
You will work with the Designated Individuals for the HTA research and postmortem licenses to ensure compliance with HTA standards. This will entail communication with senior staff across CUH and the University of Cambridge on the Cambridge Biomedical Campus.
Main duties of the job
Lead the Human Tissue Authority (HTA) Regulatory, Governance and Compliance team to ensure that work stream around the Research and Post Mortem Licences, and programmes are planned and carried out effectively across the Biomedical Research Campus. Lead the provision of an efficient, effective and high quality regulatory and quality programme, capable of meeting all statutory, regulatory and HTA compliance requirements ensuring alignment with the activity of the organization and the Biomedical Research Campus.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 12000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 17th April 2024.
Interviews are due to be held on the 26th April 2024.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 17th April 2024.
Interviews are due to be held on the 26th April 2024.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases, alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- Educated to Masters level or equivalent level of experience of working at a senior level in specialist area.
Desirable
- Management qualification or equivalent experience.
- Project management qualification.
Experience
Essential
- Must have experience of working in a quality or compliance role at a senior level.
- Must have an understanding of the background to and aims of current HTA regulations and appreciate the implications of this on engagement.
- Should have an appreciation of research governance and the relationship between NHS and research.
Desirable
- Experience of working in R&D or Mortuary.
- Previous HTA Designated Individual Experience.
Knowledge
Essential
- Extensive knowledge of regulatory and compliance with HTA , acquired through post graduate diploma or equivalent experience or training plus further specialist knowledge or experience to master's level equivalent.
- Knowledge and understanding of equality and diversity taking into account and being aware of how individual actions contribute to and make a difference to the equality agenda.
- Experience of leading HTA inspection process.
Skills
Essential
- Highly developed quality management skills, including audit, document control, and management of non-conformance.
- Risk management.
- Able to plan and organise a broad range of complex activities, formulating and adjusting plans to reflect changing circumstances.
- Must be able to provide and receive highly complex, sensitive and contentious information, negotiate with senior stakeholders on difficult and controversial issues, and present complex and sensitive information to large and influential groups.
- Able to contribute to strategic plans across CUH and within the specific teams with respect to the use of human tissue samples for scheduled purposes as defined in the Human Tissue Act.
- Ability to persuade senior managers of the respective merits of different options, Able to negotiate on difficult and very complex and detailed issues.
- Able to work with stakeholders to develop performance improvement plans and the development of improved quality management systems.
- Able to make good use of available information sources to enable efficient and effective planning.
- Ability to work under pressure and autonomously.
- Skills for direct line management and job management.
- Skills for delivering results through managing others and using a range of levers in the absence of direct line management responsibility.
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
- Working knowledge of Microsoft Office applications with intermediate keyboard skills.
- An ability to maintain confidentiality and trust values.
- Accustomed to working in a busy environment.
- Adaptability, flexibility and ability to cope with uncertainty and change.
- Commitment to continuing professional development..
Person Specification
Qualifications
Essential
- Educated to Masters level or equivalent level of experience of working at a senior level in specialist area.
Desirable
- Management qualification or equivalent experience.
- Project management qualification.
Experience
Essential
- Must have experience of working in a quality or compliance role at a senior level.
- Must have an understanding of the background to and aims of current HTA regulations and appreciate the implications of this on engagement.
- Should have an appreciation of research governance and the relationship between NHS and research.
Desirable
- Experience of working in R&D or Mortuary.
- Previous HTA Designated Individual Experience.
Knowledge
Essential
- Extensive knowledge of regulatory and compliance with HTA , acquired through post graduate diploma or equivalent experience or training plus further specialist knowledge or experience to master's level equivalent.
- Knowledge and understanding of equality and diversity taking into account and being aware of how individual actions contribute to and make a difference to the equality agenda.
- Experience of leading HTA inspection process.
Skills
Essential
- Highly developed quality management skills, including audit, document control, and management of non-conformance.
- Risk management.
- Able to plan and organise a broad range of complex activities, formulating and adjusting plans to reflect changing circumstances.
- Must be able to provide and receive highly complex, sensitive and contentious information, negotiate with senior stakeholders on difficult and controversial issues, and present complex and sensitive information to large and influential groups.
- Able to contribute to strategic plans across CUH and within the specific teams with respect to the use of human tissue samples for scheduled purposes as defined in the Human Tissue Act.
- Ability to persuade senior managers of the respective merits of different options, Able to negotiate on difficult and very complex and detailed issues.
- Able to work with stakeholders to develop performance improvement plans and the development of improved quality management systems.
- Able to make good use of available information sources to enable efficient and effective planning.
- Ability to work under pressure and autonomously.
- Skills for direct line management and job management.
- Skills for delivering results through managing others and using a range of levers in the absence of direct line management responsibility.
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of safe, kind, excellent.
- Working knowledge of Microsoft Office applications with intermediate keyboard skills.
- An ability to maintain confidentiality and trust values.
- Accustomed to working in a busy environment.
- Adaptability, flexibility and ability to cope with uncertainty and change.
- Commitment to continuing professional development..
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
Cambridge University Hospital NHS Foundation Trust
Address
Addenbrookes Hospital-Division R&D
Hills Road
Cambridge
CB2 0QQ
Employer's website
https://www.cuh.nhs.uk (Opens in a new tab)