Quality Assurance Support Officer

1 week ago

Bangor, United Kingdom Bangor University Full time

Applications are invited for the above full-time position within the North Wales Organisation for Randomised Trials in Health and Social Care (NWORTH).

The post-holder will be accountable to the NWORTH Interim Director and will report to the Quality Assurance Officer.

Excellent communication skills and the ability to communicate effectively and purposefully with a wide range of internal and external collaborators is essential. The postholder will have the support of the QA Officer and other team members although a level of self-motivation is essential. The role is full-time.

The ability to communicate in Welsh is desirable for this post.

Applications will also be considered to carry out this role on a part-time or job share basis.

Committed To Equal Opportunities

Overview

Bangor is situated in the beautiful area of North West Wales between the mountains of Snowdonia and the famous Menai Straits. It offers unparalleled access to a wide range of outdoor pursuits including, climbing, walking, kayaking and sailing. With rail and dual carriageway access along the coasts to Liverpool and Manchester and a fast rail route to London, Bangor University’s location enables its staff and students to work and study in unrivalled natural surroundings, whilst still having access to the major conurbations. Founded in 1884 and dedicated to academic excellence, in the recent Research Exercise Framework, it out-performed expectations in Healthcare Sciences, Psychology and Sports and Exercise Science. Three
- quarters of Bangor’s research was classed as either world-leading or internationally excellent, ahead of the average for all UK Universities. It has over 9,000 students, 26 academic schools and over 550 research-active staff.

College of Human Sciences (CHS):
The College of Human Sciences is one of five colleges at Bangor, a university that has regularly appeared in the top ten for ‘Student Satisfaction” in the National Student Survey. Bangor is a high calibre research led institution with over half of its Schools ranked in the top 20 in the UK in the Research Exercise Framework (REF) of 2014. With over 3,000 students and over 400 academic and support staff CHS is a substantial part of the University and the College’s member schools are
- School of Medical and Health Sciences - Research Excellence Framework Top 20
- School of Educational Sciences
- School of Human & Behavioural Sciences

The research within CHS has had varied and wide ranging real world benefits in areas such as the economy, society, health and quality of life both within the UK and on the global stage and Faculty have research and consultancy links with a wide range of external organisations.

The College, through the University, is formally linked to the Betsi Cadwaladr University Health Board enabling an integrated approach to developing research, training, medical and healthcare education that serves the needs of North Wales and beyond.

The School of Medical and Health Sciences:
North Wales Organisation for Randomised Trials in Health (NWORTH):
The North Wales Organisation for Randomised Trials in Health is a registered clinical trials unit (CTU) which has full UKCRC registration and is one of the elements within the Health and Care Research Wales Infrastructure. The CTU is part funded by the Welsh Government, with key members of the team funded by an infrastructure grant from Health and Care Research Wales.

Purpose of the Job

The post is to provide support to the Quality Assurance function at NWORTH. fAs part of an established team working in the area of clinical trials, the postholder will work closely with the QA Officer to ensure NWORTH Clinical Trials Unit is compliant with national and international standards for the conduct of health research including:
Research Governance Framework for Health & Social Care (2005), the World Medical Association Declaration of Helsinki (1996), Principles of ICH-GCP, and the current regulatory requirements, as detailed in the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK S.I. 2004/1031) and any subsequent amendments of the clinical trial regulations.

Main

**Responsibilities**:

- Facilitate the development and maintenance of NWORTH’s suite of Standard Operating Procedures, ensuring that all systems are in line with any policies and procedures of Bangor University.- Assist in the oversight the archiving function of all research materials.- Complete internal audits in line with agreed internal audit schedule.- In conjunction with cross functional teams assist in the develop risk assessments and audit processes for all research projects to ensure Good Clinical Practice (GCP) compliance.- Support research-specific activities such as Health Research Authority and Medical and Healthcare products Regulatory Agency submissions for trials to ensure compliance with regulatory requirements.- Where required assist with the preparation for inspections by regulatory authorities such as M

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