Job Advert
NHS Greater Glasgow and Clyde is one of the largest healthcare systems in the UK employing around 40,000 staff in a wide range of clinical and non-clinical professions and job roles. We deliver acute hospital, primary, community and mental health care services to a population of over 1.15 million and a wider population of 2.2 million when our regional and national services are included.
Glasgow Clinical Research Facility (GCRF) incorporates Clinical Research Facilities at QEUH, the GRI and Children’s Clinical Research Facility at QEUH. Jointly they provide a streamlined service to investigators to conduct their clinical research efficiently and safely.
We are recruiting an enthusiastic Quality Assurance (QA) Lead to provide expert knowledge, skills and training in all aspects of Quality Assurance (QA) across the Glasgow Clinical Research Facility services and sites, in accordance with applicable legislations, standards and frameworks governing clinical research.
The post holder will support the development of a quality policy and strategy in the CRF, planning and delivering quality management initiatives to meet the requirements of clinical research regulations and promoting a culture of continuous quality improvement.
Minimum requirements:
Educated to Masters’ level in a clinical or life sciences related subject or equivalent post-graduate experience in order to interpret, analyse and write technical documents and reports at an academic and theoretical level
Evidence of further education in quality assurance / quality management - evidence of Continuous Professional Development.
Current up to date training in Good Clinical Practice (GCP)
Highly developed working knowledge of regulatory frameworks and legislation governing the conduct of clinical research. These include but are not restricted to: the Research Governance Framework for Health and Community Care, Medicines for Human Use (Clinical Trials) Regulations, Adults with Incapacity (Scotland) Act, Data Protection Act, Governance Arrangements for Research Ethics Committees and Human Tissue Acts.
Evidence of undertaking, co-ordinating or managing clinical research within a senior research role, demonstrating experience of working on phase I, II and III clinical trials.
Evidence of continuing professional development within a management role
Self-motivated with ability to motivate and influence others, demonstrating well developed negotiation skills, diplomacy and good judgement.
Able to demonstrate the application of advanced, specialist QA knowledge through the development, implementation and management of quality systems in a clinical research environment
Proven experience of managing change effectively.
Experience of leading QA preparation for, participation in and response to regulatory inspection.
Knowledge and understanding of the MHRA Phase I Accreditation Scheme with awareness of the implications for quality systems and quality assurance in hospital based clinical research units
Excellent communication skills (oral, written & presentation) with proven ability to write reports and present complex information to a variety of stakeholders, whilst working effectively as part of a team.
Excellent time management skills – able to plan and work to agreed timescales and to multi-task effectively under pressure, maintaining high quality work.
Proven ability to maintain highly complex information sources and databases
Experience in delivering formal training.
Proficient in the use of Microsoft Office applications.
Informal Contact: Naomi Hickey, Education and Quality Lead, Tl No: 0141 232 7600
Details on how to contact the Recruitment Service can be found within the Candidate Information Packs
NHS Greater Glasgow and Clyde- NHS Scotland encourages applications from all sections of the community. We promote a culture of inclusion across the organisation and are proud of the diverse workforce we have.
By signing the Armed Forces Covenant, NHSGGC has pledged its commitment to being a Forces Friendly Employer. We support applications from across the Armed Forces Community, recognising military skills, experience and qualifications during the recruitment and selection process.
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