Job summary
We are seeking a bright and motivated Quality Assurance Manager for the NIHR King's Clinical Research Facility. In this exciting role the post holder will maintain systems to assure the quality of clinical research undertaken within the Clinical Research Facility in accordance with prevailing legislative and best practice requirements, including Good Manufacturing Practice, Good Laboratory Practice principles, the Research Governance Framework for Health and Community Care 2005, Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations, the Human Tissue Act and the Mental Capacity Act. The post holder will play a key role in the co-ordination of working practices and policy implementation to ensure that the Clinical Research Facility is at all times compliant with both internal policies and external regulatory frameworks. They will have an expert knowledge of those regulatory frameworks and will be able to liaise at a high level with all stakeholders within KHP. The post holder will be based at the Denmark Hill CRF but will be expected to work closely with the counterparts at the Guy's and St Thomas' across both CRFs.
The post holder will make autonomous professional decisions on a daily basis relating to the initiation, development and implementation of quality assurance systems in the CRF.
Main duties of the job
Manage and maintain the quality control of clinical research activity undertaken within the CRF.
Ensure that all changes to existing working practices and the introduction of new working practices and policies are implemented in the CRF using robust and standardised systems.
Develop, implement, review and verify CRF working practices and standard operating procedures, ensuring that all Regulatory, College and Trust requirements are encapsulated.
Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors on demand.
Recognise and respond to research governance and quality issues that might arise during quality control checks.
Review and risk assess the CRFs clinical trial portfolio in order to identify high-risk studies and target the use of Quality Control systems
Recognise and act upon departures from legislative and research governance requirements including failure to follow protocols and or SOPs, responding appropriately and escalating action as required.
Participate in regulatory inspections and audits as required
Lead the preparation for mandatory inspection of the CRF by the MHRA, developing and maintaining an inspection implementation plan, in order to ensure that the CRF remains in a state of readiness for statutory inspection.
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
Management of Quality Assurance in the Clinical Research Facility
To oversee and ensure that the Vertical Laminar Flow Cabinet (VLFC) is fully operational and its operators are trained in aseptic techniques as well as supervise all training until the staff member is competent. To ensure that all staff performing tasks within the VLFC have completed and passed a Broth and Operator Transfer Disinfection validation. To perform all pre-sessional environmental and microbiological monitoring and to liaise with CTU team to obtain these test results prior to IMP preparation within the VLFC. To ensure that all the equipment is serviced and calibrated regularly at a period of once every 12 months by the manufacturer (Monmouth Scientific). To ensure that subsequent PQs are performed each year. To ensure that all calibration and validation (Installation Qualification, Operational Qualification and Performance Qualification), results are stored and recorded on QPulse.
Oversee and monitor systems for the procurement, processing and storage of biological samples ensuring that such activity is undertaken within the terms of Human Tissue legislation, ethical approval and the necessary requirements of the research protocol, in order to make certain that safe handling, ethical integrity and quality is assured.
Oversee and record annual systems tests e.g. emergency evacuation procedure, identifying any system failures and acting to resolve them, in order to demonstrate that the CRF meets the required safety standards for hosting clinical research studies Organise and conduct mock inspections of the CRF, in order to check that facilities, services and staff are prepared for regulatory inspection and that individual staff members are aware of their research governance responsibilities.
Prepare and present regular internal audit reports to the CRF Operational Management Team in order to ensure that the CRF Directors and Clinical Research Manager are fully appraised of any systems gaps requiring remedial action and alerted to any breaches of research governance legislation requiring corporate action.
Indirectly assist clinicians in conducting high quality research which leads directly to changes in patient care, NHS services and better evidence- based practice.
Act as lead Health and Safety Advisor for the CRF, ensuring that the facility is complying with all local Trust and regulatory requirements.
Responsible for completing and submitting the annual Trust Health and Safety returns and for drafting and maintaining CRF Health and Safety Code of Practice and risk assessments.
Attend, and contribute to regular CRF Management, Clinical Governance and Health and Safety Meetings and Trust-wide and Divisional Risk Meetings.
Responsible for management of the CRF local induction and training programme for staff and users of the facility.
Job description
Job responsibilities
Management of Quality Assurance in the Clinical Research Facility
To oversee and ensure that the Vertical Laminar Flow Cabinet (VLFC) is fully operational and its operators are trained in aseptic techniques as well as supervise all training until the staff member is competent. To ensure that all staff performing tasks within the VLFC have completed and passed a Broth and Operator Transfer Disinfection validation. To perform all pre-sessional environmental and microbiological monitoring and to liaise with CTU team to obtain these test results prior to IMP preparation within the VLFC. To ensure that all the equipment is serviced and calibrated regularly at a period of once every 12 months by the manufacturer (Monmouth Scientific). To ensure that subsequent PQs are performed each year. To ensure that all calibration and validation (Installation Qualification, Operational Qualification and Performance Qualification), results are stored and recorded on QPulse.
Oversee and monitor systems for the procurement, processing and storage of biological samples ensuring that such activity is undertaken within the terms of Human Tissue legislation, ethical approval and the necessary requirements of the research protocol, in order to make certain that safe handling, ethical integrity and quality is assured.
Oversee and record annual systems tests e.g. emergency evacuation procedure, identifying any system failures and acting to resolve them, in order to demonstrate that the CRF meets the required safety standards for hosting clinical research studies Organise and conduct mock inspections of the CRF, in order to check that facilities, services and staff are prepared for regulatory inspection and that individual staff members are aware of their research governance responsibilities.
Prepare and present regular internal audit reports to the CRF Operational Management Team in order to ensure that the CRF Directors and Clinical Research Manager are fully appraised of any systems gaps requiring remedial action and alerted to any breaches of research governance legislation requiring corporate action.
Indirectly assist clinicians in conducting high quality research which leads directly to changes in patient care, NHS services and better evidence- based practice.
Act as lead Health and Safety Advisor for the CRF, ensuring that the facility is complying with all local Trust and regulatory requirements.
Responsible for completing and submitting the annual Trust Health and Safety returns and for drafting and maintaining CRF Health and Safety Code of Practice and risk assessments.
Attend, and contribute to regular CRF Management, Clinical Governance and Health and Safety Meetings and Trust-wide and Divisional Risk Meetings.
Responsible for management of the CRF local induction and training programme for staff and users of the facility.
Person Specification
Education
Essential
- Educated to degree level or equivalent in a clinical or life sciences related subject.
- Evidence of further education including post-graduate certification / diploma / Continuous Professional Development in clinical research
- Trained in ICH GCP (International Conference on Harmonisation Good Clinical Practice).
Experience
Essential
- An extensive experience undertaking, co-ordinating or managing clinical research. (academic or commercial setting) preferably involving phase I, II and III clinical trials.
- Proven experience of developing and implementing health and safety procedures in a clinical or laboratory environment
- Up to date knowledge of major regulatory issues governing the conduct of clinical research (Research Governance Framework for Health and Community Care, Medicines for Human Use (Clinical Trials) Regulations, Adults with Incapacity (Scotland) Act, Data Protection Act, Governance Arrangements for Research Ethics Committees and Human Tissue Act).
Desirable
- Knowledge and experience using the Q Pulse system
- Knowledge and experience with VLFC
Skills and Competencies
Essential
- Proven project management and organisational skills
- Excellent communication skills (oral, written & presentation) with proven ability to work effectively as part of a team.
Desirable
Person Specification
Education
Essential
- Educated to degree level or equivalent in a clinical or life sciences related subject.
- Evidence of further education including post-graduate certification / diploma / Continuous Professional Development in clinical research
- Trained in ICH GCP (International Conference on Harmonisation Good Clinical Practice).
Experience
Essential
- An extensive experience undertaking, co-ordinating or managing clinical research. (academic or commercial setting) preferably involving phase I, II and III clinical trials.
- Proven experience of developing and implementing health and safety procedures in a clinical or laboratory environment
- Up to date knowledge of major regulatory issues governing the conduct of clinical research (Research Governance Framework for Health and Community Care, Medicines for Human Use (Clinical Trials) Regulations, Adults with Incapacity (Scotland) Act, Data Protection Act, Governance Arrangements for Research Ethics Committees and Human Tissue Act).
Desirable
- Knowledge and experience using the Q Pulse system
- Knowledge and experience with VLFC
Skills and Competencies
Essential
- Proven project management and organisational skills
- Excellent communication skills (oral, written & presentation) with proven ability to work effectively as part of a team.
Desirable
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).
