Job summary
Are you interested in being part of Healthcare research?
Are you meticulous, organised and have recent experience of working on Research Trials or within Research Quality Assurance, then this is the role for you.
We are a small supportive Quality Assurance Team within Research & Development that can offer training to develop your skills in Quality Assurance, which will include auditing and compliance assessments.
Main duties of the job
You will be required to undertake Audits of Research studies within the trust to ensure that they are compliant with national legislation and local policies and procedures, producing reports and recommendations based on your findings and escalating concerns accordingly.
You will implement new and updated working practices within R&D based on updated guidance's, legislation, or Audit findings.
You will be responsible for the document management system that support the work of Quality Assurance Team and Research Delivery in the trust.
While this role does offer some remote working, you will be required on site to undertake Audits.
About us
Oxford Health NHS Foundation Trust provides physical, mental health and social care for people of all ages across Oxfordshire, Buckinghamshire, Swindon, Wiltshire, Bath and North East Somerset.
Our services are delivered at community bases, hospitals, clinics and people's homes, delivering care as close to home as possible
Our vision is that no matter who you are or where you are, you will tell us that you receive:"Outstanding care delivered by an outstanding team"
Our values are:"Caring, safe and excellent"
At Oxford Health we offer a wide range of benefits designed to support your career and wellbeing. These include:
- Excellent opportunities for career progression
- Access to tailored individual and Trust wide learning and development
- 27 days annual leave, plus bank holidays, rising to 33 days with continuous service
- NHS Discount across a wide range of shops, restaurants and retailers
- Competitive pension scheme
- Lease car scheme
- Cycle to work scheme
- Employee Assistance Programme
- Mental Health First Aiders
- Staff accommodation (please note waiting lists may apply)
- Staff networking and support groups hosted by our Equality, Diversity & Inclusion team
Job description
Job responsibilities
Quality Assurance in Research and Development
The post holder is expected to, Implement and maintain the systems which provide assurance of the quality ofclinical research activity undertaken within the Trust. Recognise and respond to research governance and quality issues that might ariseduring quality control checks. Participate in the hosting of regulatory inspections and audits as required. Promote a Quality Culture among R&D staff, users and the wider clinical research community. Act as local administrator and lead user of key Quality Assurance software in R&D, and as the local expert and primary liaison with Trust IT and the software vendor for these systems. The post holder will ensure that all systems meet the operational needs of the R&D at all times and will be responsible for the development andvalidation of associated systems and processes as required by the QA Manager.
Document Management Take responsibility for developing the R&D portfolio of quality documents includingSOPs, Work Instructions, supporting Templates etc., in conjunction with the subjectmatter experts (authors) as appropriate under the direct supervision of the QAManager. Manage change, implementing new and updated working practices within R&D andensuring they are appropriately documented. Ensure that all Regulatory, and Trust requirements are encapsulated in the QualitySystem. Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors ondemand.
Audit Implement the R&D systems audit programme to ensure that the Quality System isbeing implemented appropriately and fit for purpose. Recognise and act upon departures from legislative and research governancerequirements including failure to follow protocols and /or SOPs, respondingappropriately and escalating action as required. Participate in Good Clinical Practice audits of research studies running in the Trustand on as part of the audit programme implemented by the QA Manager.
Accreditation Develop and maintain expert knowledge of any accreditation requirements andassociated guidelines, and how they apply in the R&D operational context shouldthey be required, e.g. MHRA phase 1 accreditation or Work closely with high-level stakeholders across the department and within researchteams to implement the plan for maintenance of any required accreditation underthe supervision of the QA Manager. Maintain oversight of risks of any accreditation programme undertaken. Produce regular reports for the Senior R&D management team to communicate progress with the maintenance plan and escalating risks as appropriate.
Sample Processing Laboratories The post holder will work closely with lab leads, providing quality assurance support to ensure that the Research laboratories are compliant with relevant standards and legislation including HSE & ACDP Guidance, COSHH regulations, GCLP etc.
Information and Data Management The post holder will use standard information technology - Word, Excel, PowerPoint, Access, Internet Explorer and R&D specific software in order to undertake theirduties. The post holder will collate and present routine quality information in a timely andaccurate manner to agreed formats and timescales ensuring that clear interpretationhave been made. They will use the Trust reporting systems and AMAT the trust auditing software They will ensure that all paper-based systems are maintained securely. They will oversee the storage and archiving of records in accordance with therelevant procedures and requirements.
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 act as the R&D QA expert on quality matters pertaining to clinical trials. Attend national meetings on behalf of the service. Possess excellent communication skills, allowing the post holder to justify theirdecisions and influence others, communicating effectively and calmly in difficultsituations. Maintain good working relationships with academic and service departments topromote effective teamwork. Be able to work autonomously always adhering to departmental operatingprocedures and protocols.
Job description
Job responsibilities
Quality Assurance in Research and Development
The post holder is expected to, Implement and maintain the systems which provide assurance of the quality ofclinical research activity undertaken within the Trust. Recognise and respond to research governance and quality issues that might ariseduring quality control checks. Participate in the hosting of regulatory inspections and audits as required. Promote a Quality Culture among R&D staff, users and the wider clinical research community. Act as local administrator and lead user of key Quality Assurance software in R&D, and as the local expert and primary liaison with Trust IT and the software vendor for these systems. The post holder will ensure that all systems meet the operational needs of the R&D at all times and will be responsible for the development andvalidation of associated systems and processes as required by the QA Manager.
Document Management Take responsibility for developing the R&D portfolio of quality documents includingSOPs, Work Instructions, supporting Templates etc., in conjunction with the subjectmatter experts (authors) as appropriate under the direct supervision of the QAManager. Manage change, implementing new and updated working practices within R&D andensuring they are appropriately documented. Ensure that all Regulatory, and Trust requirements are encapsulated in the QualitySystem. Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors ondemand.
Audit Implement the R&D systems audit programme to ensure that the Quality System isbeing implemented appropriately and fit for purpose. Recognise and act upon departures from legislative and research governancerequirements including failure to follow protocols and /or SOPs, respondingappropriately and escalating action as required. Participate in Good Clinical Practice audits of research studies running in the Trustand on as part of the audit programme implemented by the QA Manager.
Accreditation Develop and maintain expert knowledge of any accreditation requirements andassociated guidelines, and how they apply in the R&D operational context shouldthey be required, e.g. MHRA phase 1 accreditation or Work closely with high-level stakeholders across the department and within researchteams to implement the plan for maintenance of any required accreditation underthe supervision of the QA Manager. Maintain oversight of risks of any accreditation programme undertaken. Produce regular reports for the Senior R&D management team to communicate progress with the maintenance plan and escalating risks as appropriate.
Sample Processing Laboratories The post holder will work closely with lab leads, providing quality assurance support to ensure that the Research laboratories are compliant with relevant standards and legislation including HSE & ACDP Guidance, COSHH regulations, GCLP etc.
Information and Data Management The post holder will use standard information technology - Word, Excel, PowerPoint, Access, Internet Explorer and R&D specific software in order to undertake theirduties. The post holder will collate and present routine quality information in a timely andaccurate manner to agreed formats and timescales ensuring that clear interpretationhave been made. They will use the Trust reporting systems and AMAT the trust auditing software They will ensure that all paper-based systems are maintained securely. They will oversee the storage and archiving of records in accordance with therelevant procedures and requirements.
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 act as the R&D QA expert on quality matters pertaining to clinical trials. Attend national meetings on behalf of the service. Possess excellent communication skills, allowing the post holder to justify theirdecisions and influence others, communicating effectively and calmly in difficultsituations. Maintain good working relationships with academic and service departments topromote effective teamwork. Be able to work autonomously always adhering to departmental operatingprocedures and protocols.
Person Specification
Knowledge Requirements
Essential
- Understanding of regulatory requirements as they relate to QA.
- Ability to demonstrate technical knowledge and skills in managing QA
Desirable
- Prior experience of performing audit
- Experience of training others
Qualifications/Education/Skills
Essential
- Relevant degree in Psychology, Health, Biological Sciences or Medical related field Or Relevant demonstrable experience with knowledge relating to Quality Assurance equating to a degree level.
- Strong problem solving skills.
- Ability to identify and prioritise work.
- Ability to communicate effectively with roles at all levels within the organisation, negotiating effective outcomes.
Experience
Essential
- Recent experience of working on Clinical Trials of Investigational Medicinal Products (CTIMPs), working to the UK Statutory Instruments for clinical trials and ICH Good Clinical Practice
- Experience of clinical trial quality control e.g. monitoring, Auditing Experience of writing and reviewing standard operating procedures
Desirable
- Previous experience of a quality management system and the management of GCP operations
- Experience of trials in all phases of research particularly Phase I clinical trials
Personal Qualities
Essential
- Able to work individually and as part of a team.
- Ability to build effective professional relationships at all levels with various departments
Person Specification
Knowledge Requirements
Essential
- Understanding of regulatory requirements as they relate to QA.
- Ability to demonstrate technical knowledge and skills in managing QA
Desirable
- Prior experience of performing audit
- Experience of training others
Qualifications/Education/Skills
Essential
- Relevant degree in Psychology, Health, Biological Sciences or Medical related field Or Relevant demonstrable experience with knowledge relating to Quality Assurance equating to a degree level.
- Strong problem solving skills.
- Ability to identify and prioritise work.
- Ability to communicate effectively with roles at all levels within the organisation, negotiating effective outcomes.
Experience
Essential
- Recent experience of working on Clinical Trials of Investigational Medicinal Products (CTIMPs), working to the UK Statutory Instruments for clinical trials and ICH Good Clinical Practice
- Experience of clinical trial quality control e.g. monitoring, Auditing Experience of writing and reviewing standard operating procedures
Desirable
- Previous experience of a quality management system and the management of GCP operations
- Experience of trials in all phases of research particularly Phase I clinical trials
Personal Qualities
Essential
- Able to work individually and as part of a team.
- Ability to build effective professional relationships at all levels with various departments
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.
