Job summary
Quality Assurance Officer - Band 5
£37,259 - £45,356 Inclusive of HCAS Per annum Pro rata
Fixed term: 12 months - Full time 37.5 hours per week
The post holder will support and maintain a quality management system to assure the quality of clinical research undertaken within the Research and Development Department in accordance with prevailing legislative and best practice requirements, including Good Manufacturing Practice, Good Laboratory Practice principles, the Research Governance Framework for Health and Social Care 2005, Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations (as amended from time to time), the Human Tissue Act, the Data Protection Act and the Mental Capacity Act.
Main duties of the job
The post holder will play a role in the co-ordination of working practices and policy implementation to ensure that the Trust is at all times compliant with both internal policies and external regulatory frameworks.
The post holder will drive a quality approach to the conduct of commercial and non-commercial clinical research to ensure that clinical trial quality is assured throughout all areas within the Trust where clinical research is undertaken.
The post holder will be based in the Trust R&D department and will work across the Denmark Hill and PRUH sites.
About us
King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c£1.8 billion, 1.5 million patient contacts a year and more than 15,000 staff based across South East London.
The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level.
We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.
King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.
Job description
Job responsibilities
Supporting Quality Assurance and Audit Programme
- In conjunction with the R&D Operational Manager, set up and manage the quality control of clinical research activity undertaken within the R&D Office.
- Develop, implement, review and verify R&D working practices and standard operating procedures, ensuring that all Regulatory, College and Trust requirements are encapsulated.
- Implement and maintain office systems to manage working practices and policies within the Trust.
- Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors on demand.
R&D Governance and Risk
- Preparing reports of InPhase incidents across the Trust for the Research Governance and Risk committee on a quarterly basis.
-
R&D Audit Programme
- Assist in the hosting of regulatory inspections and audits as required.
- Participate in Good Clinical Practice audits of research studies running in the CRF and on occasion within the wider Trust as part of the audit programme implemented by the R&D Operational Manager.
Information and Data Management
- The post holder will use standard information technology - Word, Excel, PowerPoint, Access, Internet Explorer and the CRF specific software in order to undertake their duties.
- They will use the Trust systems InPhase, CRF Manager, Q-Pulse, Edge and other relevant reporting systems.
Please refer to the attached job description and person specification for further details of the main responsibilities of the role.
Job description
Job responsibilities
Supporting Quality Assurance and Audit Programme
- In conjunction with the R&D Operational Manager, set up and manage the quality control of clinical research activity undertaken within the R&D Office.
- Develop, implement, review and verify R&D working practices and standard operating procedures, ensuring that all Regulatory, College and Trust requirements are encapsulated.
- Implement and maintain office systems to manage working practices and policies within the Trust.
- Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors on demand.
R&D Governance and Risk
- Preparing reports of InPhase incidents across the Trust for the Research Governance and Risk committee on a quarterly basis.
-
R&D Audit Programme
- Assist in the hosting of regulatory inspections and audits as required.
- Participate in Good Clinical Practice audits of research studies running in the CRF and on occasion within the wider Trust as part of the audit programme implemented by the R&D Operational Manager.
Information and Data Management
- The post holder will use standard information technology - Word, Excel, PowerPoint, Access, Internet Explorer and the CRF specific software in order to undertake their duties.
- They will use the Trust systems InPhase, CRF Manager, Q-Pulse, Edge and other relevant reporting systems.
Please refer to the attached job description and person specification for further details of the main responsibilities of the role.
Person Specification
Education & Qualifications
Essential
- Relevant degree or professional qualification or equivalent experience
- Advanced IT skills, ECDL or proven equivalent experience in MS Office, email and Internet browsers
Desirable
- Good Clinical Practice training
Knowledge and Experience
Essential
- Excellent oral and written communication skills to communicate effectively with researchers, consultants and staff from different disciplines and administrators at all levels
- Ability to communicate healthcare research information in an easily understood manner.
- Risk and incident management experience in the NHS or pharmaceutical industry environment.
Desirable
- Basic understanding of medical terminology.
Skills and Competencies
Essential
- Strong planning and organizational skills including the ability to prioritize, manage multiple tasks and projects, with proven ability to deliver to stringent performance criteria within agreed deadlines.
- Strong ability to problem solve.
- Strong ability to build successful relationships and collaborate in a cross functional team and maintain a positive work environment.
- Resilience and flexibility; able to contribute innovatively to solving process development problems.
- Well motivated with evidence of an ability to work without direct supervision and to use own initiative.
- Ability to develop and maintain good working relationships with all levels of staff
- Highly professional approach to work, in particular in dealing with confidential information.
Person Specification
Education & Qualifications
Essential
- Relevant degree or professional qualification or equivalent experience
- Advanced IT skills, ECDL or proven equivalent experience in MS Office, email and Internet browsers
Desirable
- Good Clinical Practice training
Knowledge and Experience
Essential
- Excellent oral and written communication skills to communicate effectively with researchers, consultants and staff from different disciplines and administrators at all levels
- Ability to communicate healthcare research information in an easily understood manner.
- Risk and incident management experience in the NHS or pharmaceutical industry environment.
Desirable
- Basic understanding of medical terminology.
Skills and Competencies
Essential
- Strong planning and organizational skills including the ability to prioritize, manage multiple tasks and projects, with proven ability to deliver to stringent performance criteria within agreed deadlines.
- Strong ability to problem solve.
- Strong ability to build successful relationships and collaborate in a cross functional team and maintain a positive work environment.
- Resilience and flexibility; able to contribute innovatively to solving process development problems.
- Well motivated with evidence of an ability to work without direct supervision and to use own initiative.
- Ability to develop and maintain good working relationships with all levels of staff
- Highly professional approach to work, in particular in dealing with confidential 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).
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
King's College Hospital NHS Foundation Trust
Address
King's College Hospital NHS Foundation Trust
Denmark Hill
London
SE5 9RS
Employer's website
https://www.kch.nhs.uk/ (Opens in a new tab)
