Job summary
We are excited to recruit a dynamic, out-going person as a R&D Quality Assurance Officer. The key aim of the role will be to develop relationships with researchers and other staff to ensure cooperation with the quality agenda. Good IT skills are essential and the successful applicant should be able to provide evidence of continuing professional development.
Main duties of the job
Attached you will find the person specification document which provides more detail about the essential and desirable skills and experience needed for this role. We highly recommend you review this document and use it when completing your application as these criteria are used by hiring managers as guidance during shortlisting.
For an overview of the main duties of the role please see the 'Job Description and Main Responsibilities' section below. To understand the day-to-day responsibilities in more detail please read the full job description document attached.
About us
University Hospital Southampton NHS Foundation Trust and University of Southampton partnership is recognised as a centre of excellence in clinical research securing research funding in excess of £30m per annum.
With state of the art clinical research facilities opened in 2010, the Trust, in partnership with the University, is making excellent progress in achieving its aim of being one of the top performing research institutions in the country.
The research department is an award winning, dynamic and innovative place to work and the QA team are friendly and supportive and always looking to improve. At the time of inspections there may be some working into the evening but generally the office is manned between 8am and 5pm and on-site working will be required.
All non-clinical roles may involve a mixture of on site and remote working, Specific details and flexible working options can be discussed as part of the interview process. UHS employees are able to access a range of NHS discounts, are entitled to a minimum of 35 days paid holiday (pro rata), and we offer a generous pension scheme.
Southampton is an attractive place to live and work situated on the south coast, with an international airport and direct trains to London. The New Forest National Park and beaches of the Jurassic coast are also right on our doorstep. The city offers living costs 20% lower than London and 14 schools rated outstanding by Ofsted.
Job description
Job responsibilities
As an R&D QA Officer you will work closely with a number of teams and individuals in R&D and the wider Trust to ensure the delivery of the UHS R&D strategy meets regulatory and governance needs.
This will include:
- Supporting the Senior QA Leads and Deputy R&D QA Manager in the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Trust.
- Supporting the Trust preparation for external audit and regulatory inspection.
- Assisting in the delivery of QA initiatives to ensure that the Trust meets required standards for the conduct of clinical research.
- Assisting with the development and use of systems for recording and collating information for audits, using analytical skills to interpret metrics information required for audit reporting methods.
- Supporting the general administration of the QA team.
The following skills and experience are required for this post:
- An understanding of the governance requirements surrounding clinical research in the NHS
- An understanding of R&D issues in the NHS
- Excellent interpersonal and communication skills.
- Excellent IT skills, particularly in the use of web applications
- A flexible approach to work and the ability to adjust workload to changing priorities
Job description
Job responsibilities
As an R&D QA Officer you will work closely with a number of teams and individuals in R&D and the wider Trust to ensure the delivery of the UHS R&D strategy meets regulatory and governance needs.
This will include:
- Supporting the Senior QA Leads and Deputy R&D QA Manager in the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Trust.
- Supporting the Trust preparation for external audit and regulatory inspection.
- Assisting in the delivery of QA initiatives to ensure that the Trust meets required standards for the conduct of clinical research.
- Assisting with the development and use of systems for recording and collating information for audits, using analytical skills to interpret metrics information required for audit reporting methods.
- Supporting the general administration of the QA team.
The following skills and experience are required for this post:
- An understanding of the governance requirements surrounding clinical research in the NHS
- An understanding of R&D issues in the NHS
- Excellent interpersonal and communication skills.
- Excellent IT skills, particularly in the use of web applications
- A flexible approach to work and the ability to adjust workload to changing priorities
Person Specification
Qualifications / training required
Essential
- Educated to degree level or able to demonstrate equivalent level of knowledge and experience of administrative skills and understanding relevant to the role
- Evidence of further education and continuous professional development.
Desirable
- Recent certified training in ICH GCP, the EU Directive and UK regulations for clinical trials.
- Experience of previous training in monitoring of clinical research studies.
Previous or relevant experience necessary
Essential
- Proven experience of developing and implementing quality assurance procedures.
- Proven project or administrative management with good organisational skills.
Desirable
- Experience of change management within a research environment.
- Proven experience of managing, conducting and reporting audits.
- Experience of undergoing inspection and audit by an external authority.
Values/Behaviours
Essential
- Patients First
- Always Improving
- Working Together
Person Specification
Qualifications / training required
Essential
- Educated to degree level or able to demonstrate equivalent level of knowledge and experience of administrative skills and understanding relevant to the role
- Evidence of further education and continuous professional development.
Desirable
- Recent certified training in ICH GCP, the EU Directive and UK regulations for clinical trials.
- Experience of previous training in monitoring of clinical research studies.
Previous or relevant experience necessary
Essential
- Proven experience of developing and implementing quality assurance procedures.
- Proven project or administrative management with good organisational skills.
Desirable
- Experience of change management within a research environment.
- Proven experience of managing, conducting and reporting audits.
- Experience of undergoing inspection and audit by an external authority.
Values/Behaviours
Essential
- Patients First
- Always Improving
- Working Together
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).
