Job summary
This role with be based within the Children`s Hospital R&D offices however regular off-site monitoring and audit is part of this role
This role will involve working with NHS and University representatives and outside agencies including Principal Investigators (NHS consultants and University Researchers) and Research and Development Managers. National and Regional QA Managers. Industry and Charitable organisations involved in Research delivery. BHP and NIHR CRN WM and other research networks.
Main duties of the job
The post holder will support the R&D QA Manager to develop, implement and maintain systems to assure the quality of clinical research undertaken within the Research and Development Department and the wider research active departments in the Trust, in accordance with the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP), Good Clinical Practice for Laboratories (GLP) principles, UK Policy Framework for Health and Social Care Research and the Medicines for Human Use (Clinical Trials) Regulations 2004 as amended, and all other relevant regulations and guidelines.
The post holder will support the preparation for external audit and regulatory inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA) and lead on QA for all research active trusts within Birmingham Women`s and Children's Hospital NHS Foundation Trust.
About us
Birmingham Women's and Children's NHS Foundation Trust is the first of its type in the UK. Our Trust was formed in February 2017 to drive forward our commitment to provide the highest quality, world-class physical and mental health care for our women, children and families.
Uniting our hospitals means more seamless care; more investment to make greater advances in our specialist treatment and world-leading neo-natal and fetal work. Importantly, it also gives us a greater voice in shaping the future of family-centred care.
Birmingham Children's Hospital is a UK leading specialist paediatric centre with an international reputation in several areas. Birmingham Women's Hospital is one of two dedicated women's hospitals in the UK, with the busiest single site maternity unit, delivering more than 8,200 babies a year offering a full range of gynaecological, maternity and neonatal care. Forward Thinking Birmingham (FTB) Mental Health Services are a unique, innovative community and inpatient mental health partnership. Alongside partners FTB offers care pathways of mental health assessment and treatment for young people aged 0-25 years old.
Our Trust is committed to creating the best place to work. We believe in promoting and enhancing inclusion, diversity and equality and encourage applications from all areas of the community, who meet the criteria for the role, regardless of age, gender identity, disability, race, religion or sexual orientation.
Job description
Job responsibilities
Please refer to the attached job description and person specification to view the full details for this opportunity at Birmingham Womens and Childrens NHS Foundation Trust.
When completing your application, please ensure you have evidenced how you meet the job description and person specification to include transferable experience, qualifications, skills along with professional registration details (if applicable).
Occasionally we receive a large number of applications for our roles and when that happens we sometimes bring the closing date forward, so please apply promptly to avoid disappointment.
Job description
Job responsibilities
Please refer to the attached job description and person specification to view the full details for this opportunity at Birmingham Womens and Childrens NHS Foundation Trust.
When completing your application, please ensure you have evidenced how you meet the job description and person specification to include transferable experience, qualifications, skills along with professional registration details (if applicable).
Occasionally we receive a large number of applications for our roles and when that happens we sometimes bring the closing date forward, so please apply promptly to avoid disappointment.
Person Specification
Education
Essential
- Educated to Degree Level or equivalent experience
Desirable
- MSc in Health Related Research or equivalent experience
Knowledge and Experience
Essential
- Knowledge of current major regulatory issues governing the conduct of clinical research
- Experience in undertaking and/or co-ordinating and/or managing clinical research
Desirable
- Experience of implementing new systems within a research environment
- Project Planning Experience
Analytical Skills
Essential
- Good level of analytical skills is needed for audits and inspections
- Able to investigate incident reporting without bias and of sound judgment
Specialist Knowledge
Essential
- Knowledge of the inspection and regulation environment in which the Trust operates
- Sound knowledge of the research, Clinical Information and corporate governance agendas
- Ability to use electronic resources such as Research Databases such as EDGE
- Good knowledge of Microsoft office packages such as Word, Excel, PowerPoint, Outlook etc
Personal Skills
Essential
- Demonstrate alignment with the values and beliefs of the Trust
- Demonstrate an understanding of the practices of equality and inclusion in the delivery of this role
- Team working
- Punctual and flexible across hours of work when required
- Good interpersonal skills when liaising with internal and external personnel
- Good interpersonal skills when liaising with internal and external personnel
Person Specification
Education
Essential
- Educated to Degree Level or equivalent experience
Desirable
- MSc in Health Related Research or equivalent experience
Knowledge and Experience
Essential
- Knowledge of current major regulatory issues governing the conduct of clinical research
- Experience in undertaking and/or co-ordinating and/or managing clinical research
Desirable
- Experience of implementing new systems within a research environment
- Project Planning Experience
Analytical Skills
Essential
- Good level of analytical skills is needed for audits and inspections
- Able to investigate incident reporting without bias and of sound judgment
Specialist Knowledge
Essential
- Knowledge of the inspection and regulation environment in which the Trust operates
- Sound knowledge of the research, Clinical Information and corporate governance agendas
- Ability to use electronic resources such as Research Databases such as EDGE
- Good knowledge of Microsoft office packages such as Word, Excel, PowerPoint, Outlook etc
Personal Skills
Essential
- Demonstrate alignment with the values and beliefs of the Trust
- Demonstrate an understanding of the practices of equality and inclusion in the delivery of this role
- Team working
- Punctual and flexible across hours of work when required
- Good interpersonal skills when liaising with internal and external personnel
- Good interpersonal skills when liaising with internal and external personnel
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
Birmingham Women's and Children's NHS Foundation Trust
Address
Birmingham Children's Hospital
Steelhouse Lane
Birmingham
B4 6NH
Employer's website
https://bwc.nhs.uk/ (Opens in a new tab)
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