Quality Assurance
3 months ago
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.
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.
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.
Please refer to the attached job description and person specification to view the full details for this opportunity at Birmingham Women’s and Children’s NHS Foundation Trust.
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