Job summary
Deputy Research & Development (R&D) / Biomedical Research Centre (BRC) Quality Assurance (QA) Manager
Are you an enthusiastic, dynamic and self-motivated clinical research professional looking for a new and exciting challenge? Why not consider contributing to our ground-breaking research by joining the Research and Development department at Guy's and St. Thomas' NHS Foundation Trust, home to our National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) and Clinical Research Facility (CRF).
An exciting opportunity has arisen for a highly motivated Deputy QA Manager with proven research experience who is capable of driving and maintaining the quality of clinical research across R&D within our BRC & CRFs.
Closing Date: 19 April 2022 at Midnight
Interview Date: 28 April 2022
Main duties of the job
In this role you will support the R&D/BRC Quality Assurance Manager with the implementation, maintenance and development of the CRF Quality Management System to assure that clinical research is completed in accordance with prevailing legislative and best practice requirements, including Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations (as amended from time to time), the Human Tissue Act 2004, the General Data Protection Regulation (as implemented in the Data Protection Act 2018), MHRA Phase I Accreditation Requirements, Good Manufacturing Practice, Good Clinical Laboratory Practice, the UK Policy Framework for Health and Social Care Research 2017 and the Mental Capacity Act 2005.
You will play a key role in enabling the efficient and effective day to day operation of the CRF and work to implement Trust and CRF policy into local working practices to ensure compliance with all relevant regulatory standards and good practice guidelines at all times.
You will provide assurance that all research conducted in the CRF and across the wider R&D directorate is delivered to a consistent standard of quality, through a programme of regular review and audit. In particular, you will develop and maintain a robust understanding of MHRA Phase I accreditation requirements as they apply to research conducted within the Phase I Accredited Unit at Guy's CRF.
About us
In this role you will be working within the highly regulated environment of clinical research. With our Medicines and Healthcare products Regulatory Agency (MHRA) Phase I accreditation of our Guy's Unit you will contribute to team-wide improvement projects designed to ensure we maintain our accreditation status.
You will be based primarily within Guy's Hospital; however they will be expected to engage with and maintain a visible presence across all units of the CRF and the wider R&D directorate and act as a primary point of contact for escalation of quality queries. The post holder will make autonomous professional decisions on a daily basis relating to the initiation, development and implementation of clinical quality assurance systems in the CRF and BRC, with support and guidance from the R&D/BRC QA Manager.
Comprehensive induction, orientation and training will be provided for successful candidates. We will also ensure that you have tailored, individual personal development plans with support for further training.
Job description
Job responsibilities
Duties and Responsibilities
Quality Assurance in the Clinical Research Facilities
- Implement and maintain the systems which provide assurance of the quality of clinical research activity undertaken within the four arms of the CRF and wider BRC as required.
- Recognise and respond to research governance and quality issues that might arise or be reported by other staff.
- Act as CRF Systems Administrator and lead user of key software in the CRF, and as the local expert and primary liaison with Trust IT and the software vendor for the products listed below. The post holder will ensure that all systems meet the operational needs of the CRF at all times and will be responsible for the development and validation of associated systems and processes as required by the R&D/BRC QA Manager.
Q-Pulse Quality Management System The role will have responsibility for:
-
-
- Actively managing the portfolio of electronic documents that comprise the CRF Quality System within the software.
- Ensuring that all users (CRF core and non-core staff) are able to access the system as appropriate.
- Managing the distribution and acknowledgement of CRF quality documents for all users in compliance with the CRF Training Matrix and maintaining oversight of compliance.
- Managing processes for documentation of CRF Induction and training requirements and maintaining oversight of compliance.
- Implementing new processes using built-in software functions as required.
- Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors on demand.
- Promote a Quality Culture among BRC and CRF staff, CRF users and the wider clinical research community.
Audit and Inspection
- Implement the CRF Audit Programme to ensure that the CRF Quality System is fit for purpose.
- Lead and participate in Good Clinical Practice audits of CRF systems and processes used in the CRF as part of the audit programme implemented by the R&D / BRC Quality Assurance Manager.
- 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 the preparation for and hosting of regulatory inspections and sponsor/ CRO audits as required.
MHRA Phase I Accreditation
- Develop and maintain expert knowledge of the MHRA Phase I accreditation requirements and associated guidelines, and how they apply in the CRF operational context.
- Work closely with high-level stakeholders across the CRF and within research teams to implement the plan for maintenance of Phase I accreditation under the supervision of the R&D/BRC QA Manager.
- Produce regular reports for the CRF Management Board to communicate progress with the maintenance plan and escalating risks as appropriate.
Sample Processing Laboratories
- The post holder will work closely with the CRF Laboratory Co-ordinator, providing quality assurance support to ensure that the CRF Laboratories are compliant with relevant standards and legislation including HSE & ACDP Guidance, COSHH regulations, GCLP etc.
- The post holder will support the implementation of Connected Automated Monitoring (formerly known as Tutela), the CRF temperature monitoring system, by maintaining oversight e.g. through auditing on a regular basis.
Information and Data Management
- The post holder will use standard information technology - Word, Excel, PowerPoint, Visio, Internet Explorer and the CRF specific software such as Q-Pulse and CRFManager in order to undertake their duties.
- They will also use the Trust Reporting systems DATIX, EPR, PIMS and other relevant reporting systems.
- They will ensure that all paper based systems are maintained securely.
- They will oversee the storage and archiving of CRF records in accordance with the relevant procedures and requirements.
Line Management and Leadership
- Line Management of the CRF QA Associate, including appraisals, objective setting and performance management.
- Provide regulatory expertise and guidance to R&D, CRF and BRC staff and ensure the development of a quality culture which is facilitative to research.
- Actively contribute to the service by keeping up to date with current literature and advising appropriately.
- Promote equality and diversity and ensure policies are adhered to while applying internal processes in a fair and equal way.
General
- The post holder will maintain a high level of knowledge relating to the EU and UK legislation, regulations, management and conduct of clinical research. They will provide advice on quality matters pertaining to early phase clinical trials.
- Maintain a working relationship with the UK CRF Network.
- Attend national meetings on behalf of the service.
- Possess excellent communication skills, allowing the post holder to justify their decisions and influence others; communicating effectively and calmly in difficult situations.
- Maintain good working relationships with academic and service departments in order to promote effective teamwork.
- Be able to work autonomously adhering at all times to departmental operating procedures and protocols.
Job description
Job responsibilities
Duties and Responsibilities
Quality Assurance in the Clinical Research Facilities
- Implement and maintain the systems which provide assurance of the quality of clinical research activity undertaken within the four arms of the CRF and wider BRC as required.
- Recognise and respond to research governance and quality issues that might arise or be reported by other staff.
- Act as CRF Systems Administrator and lead user of key software in the CRF, and as the local expert and primary liaison with Trust IT and the software vendor for the products listed below. The post holder will ensure that all systems meet the operational needs of the CRF at all times and will be responsible for the development and validation of associated systems and processes as required by the R&D/BRC QA Manager.
Q-Pulse Quality Management System The role will have responsibility for:
-
-
- Actively managing the portfolio of electronic documents that comprise the CRF Quality System within the software.
- Ensuring that all users (CRF core and non-core staff) are able to access the system as appropriate.
- Managing the distribution and acknowledgement of CRF quality documents for all users in compliance with the CRF Training Matrix and maintaining oversight of compliance.
- Managing processes for documentation of CRF Induction and training requirements and maintaining oversight of compliance.
- Implementing new processes using built-in software functions as required.
- Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors on demand.
- Promote a Quality Culture among BRC and CRF staff, CRF users and the wider clinical research community.
Audit and Inspection
- Implement the CRF Audit Programme to ensure that the CRF Quality System is fit for purpose.
- Lead and participate in Good Clinical Practice audits of CRF systems and processes used in the CRF as part of the audit programme implemented by the R&D / BRC Quality Assurance Manager.
- 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 the preparation for and hosting of regulatory inspections and sponsor/ CRO audits as required.
MHRA Phase I Accreditation
- Develop and maintain expert knowledge of the MHRA Phase I accreditation requirements and associated guidelines, and how they apply in the CRF operational context.
- Work closely with high-level stakeholders across the CRF and within research teams to implement the plan for maintenance of Phase I accreditation under the supervision of the R&D/BRC QA Manager.
- Produce regular reports for the CRF Management Board to communicate progress with the maintenance plan and escalating risks as appropriate.
Sample Processing Laboratories
- The post holder will work closely with the CRF Laboratory Co-ordinator, providing quality assurance support to ensure that the CRF Laboratories are compliant with relevant standards and legislation including HSE & ACDP Guidance, COSHH regulations, GCLP etc.
- The post holder will support the implementation of Connected Automated Monitoring (formerly known as Tutela), the CRF temperature monitoring system, by maintaining oversight e.g. through auditing on a regular basis.
Information and Data Management
- The post holder will use standard information technology - Word, Excel, PowerPoint, Visio, Internet Explorer and the CRF specific software such as Q-Pulse and CRFManager in order to undertake their duties.
- They will also use the Trust Reporting systems DATIX, EPR, PIMS and other relevant reporting systems.
- They will ensure that all paper based systems are maintained securely.
- They will oversee the storage and archiving of CRF records in accordance with the relevant procedures and requirements.
Line Management and Leadership
- Line Management of the CRF QA Associate, including appraisals, objective setting and performance management.
- Provide regulatory expertise and guidance to R&D, CRF and BRC staff and ensure the development of a quality culture which is facilitative to research.
- Actively contribute to the service by keeping up to date with current literature and advising appropriately.
- Promote equality and diversity and ensure policies are adhered to while applying internal processes in a fair and equal way.
General
- The post holder will maintain a high level of knowledge relating to the EU and UK legislation, regulations, management and conduct of clinical research. They will provide advice on quality matters pertaining to early phase clinical trials.
- Maintain a working relationship with the UK CRF Network.
- Attend national meetings on behalf of the service.
- Possess excellent communication skills, allowing the post holder to justify their decisions and influence others; communicating effectively and calmly in difficult situations.
- Maintain good working relationships with academic and service departments in order to promote effective teamwork.
- Be able to work autonomously adhering at all times to departmental operating procedures and protocols.
Person Specification
Qualifications/ Education
Essential
- Masters level degree or equivalent relevant experience in QA
Previous Experience
Essential
- Extensive experience of auditing/monitoring CTIMPs
- Experience of delivering change management
- Previous experience of operating within a GxP QMS
- Experience of reviewing SOPs
- Management of GCP operations e.g. responsibility for a system/process
- Project management experience including presentation to senior colleagues
- Line management experience
Desirable
- Experience of all phases of research particularly Phase I
- Familiarity with the MHRA Phase I Accreditation requirements
- Experience in managing a GxP QMS e.g Q-Pulse
- Experience of writing and implementing SOPs
- Leadership experience
Skills/ Knowledge/Ability
Essential
- Broad working knowledge of research practices and regulations
- Ability to demonstrate technical knowledge and skills in managing QA systems and processes
- Prior experience of performing audit of GxP systems, particularly GCP
- Demonstrated excellence in planning and organisation
- Demonstrated ability to be innovative in problem solving
- Demonstrated ability to identify and prioritise work and work autonomously
- Demonstrated ability to identify and escalate risks appropriately
- Demonstrated ability to influence peers & colleagues & negotiate effective outcomes
- Ability to deputise for the R&D / BRC QA Manager as and when required to do so
- Excellent communication skills; Well-developed report writing skills and ability to deliver presentations including complex content to a multidisciplinary audience
Desirable
- Expert operational knowledge of QMS software e.g. Q-Pulse
- Experience of conducting audits independently
- Experience of training others
Person Specification
Qualifications/ Education
Essential
- Masters level degree or equivalent relevant experience in QA
Previous Experience
Essential
- Extensive experience of auditing/monitoring CTIMPs
- Experience of delivering change management
- Previous experience of operating within a GxP QMS
- Experience of reviewing SOPs
- Management of GCP operations e.g. responsibility for a system/process
- Project management experience including presentation to senior colleagues
- Line management experience
Desirable
- Experience of all phases of research particularly Phase I
- Familiarity with the MHRA Phase I Accreditation requirements
- Experience in managing a GxP QMS e.g Q-Pulse
- Experience of writing and implementing SOPs
- Leadership experience
Skills/ Knowledge/Ability
Essential
- Broad working knowledge of research practices and regulations
- Ability to demonstrate technical knowledge and skills in managing QA systems and processes
- Prior experience of performing audit of GxP systems, particularly GCP
- Demonstrated excellence in planning and organisation
- Demonstrated ability to be innovative in problem solving
- Demonstrated ability to identify and prioritise work and work autonomously
- Demonstrated ability to identify and escalate risks appropriately
- Demonstrated ability to influence peers & colleagues & negotiate effective outcomes
- Ability to deputise for the R&D / BRC QA Manager as and when required to do so
- Excellent communication skills; Well-developed report writing skills and ability to deliver presentations including complex content to a multidisciplinary audience
Desirable
- Expert operational knowledge of QMS software e.g. Q-Pulse
- Experience of conducting audits independently
- Experience of training others
