Quality Assurance Officer - Bangor, United Kingdom - Bangor University
Description
Applications are invited for the above position within the North Wales Organisation for Randomised Trials in Health and Social Care (NWORTH).
This is an exciting opportunity to join a highly motivated Clinical Trials Unit team and play a leading role in maintaining the Unit's reputation for excellence in conducting research of the highest quality. As lead for the quality assurance (QA) function at the Clinical Trials Unit, the post holder will be responsible for the Unit's quality management system and will ensure that the Unit maintains robust systems and processes to ensure compliance with national and international standards for the conduct of health and social care research.
The successful candidate will provide specialist advice to NWORTH staff, collaborators and participating centres on national and international standards for the conduct of clinical research to achieve regulatory compliance. They will be responsible for all QA activities related to the clinical trials managed by NWORTH and provide effective guidance to ensure that relevant staff are fully aware of and comply with trial regulations. They will be responsible for the Unit's Quality Management System which includes Standard Operating Procedures (SOPs), internal auditing, and investigations of non-compliance.
The post-holder will be responsible for instigating regular audits and lead on NWORTH's preparations for regulatory inspections by the Medical Healthcare products Regulatory Agency (MHRA) and will link with the UK Clinical Research Collaboration (UKCRC) QA Subgroup.
The successful candidate should have a first degree in a relevant subject, e.g. science, law, business administration, health studies or equivalent experience. A postgraduate qualification in a relevant discipline or comparable experience in clinical trials or research governance is essential.
Excellent communication skills and the ability to communicate effectively and purposefully with a wide range of internal and external collaborators is essential. The successful candidate will need the confidence to lead decisively in a fast-paced environment - identifying priorities, initiating action, taking forward multiple tasks and working independently.
The successful candidate will be expected to commence on 1st June 2024.
The role is full-time to cover a fixed-term 9-month period of maternity leave of the current Quality Assurance Officer.
Applications will also be considered to carry out this role on a part-time or job share basis.
The ability to communicate in Welsh is desirable for this post.
Prospective applicants are encouraged to contact the following for informal discussions regarding the position:
Dr Kirstie Pye, Clinical Trials Unit Manager, Phone: ; or
Dr Zoë Hoare, NWORTH Director, Phone ,
Applications will only be accepted via our on-line recruitment website, However, in cases of access issues due to disability, paper application forms are available by telephoning
Closing date for applications: 19 April 2024
Committed to Equal Opportunities
£37,099 to £44,263 per annum (Grade 7)