Quality Assurance Officer (Maternity Cover)

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: 01248 382224; [email protected]  or Dr Zoë Hoare, NWORTH Director, Phone 01248 388840, [email protected].
Applications will only be accepted via our on-line recruitment website, jobs.bangor.ac.uk. However, in cases of access issues due to disability, paper application forms are available by telephoning 01248 383865.
Closing date for applications: 19 April 2024
Committed to Equal Opportunities

Bangor University:
A reputation for excellence. Founded in 1884, Bangor University has a long tradition of academic excellence and a strong focus on the student experience. Bangor University’s research has been ranked highly in the Government’s most recent Research Excellence Framework (REF2021), with 85% judged to be world-leading (4*) or internationally excellent (3*).The University is located in an area of outstanding natural beauty, between the mountains of Snowdonia and the shores of the Menai Strait – and road and rail links to Liverpool, Manchester, London and elsewhere are excellent.

College of Medicine and Health:
The College of Medicine and Health is one of three colleges at Bangor University. 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.
North Wales Medical School:
The North Wales Medical School aims to champion and promote excellent medical and health sciences, research, scholarship, teaching and learning, quality and values with people who use services, practitioners, and stakeholders. Its mission is to promote language and cultural competence relevant to local, national and international partners, and provide an inclusive culture and environment for staff and students within the school.
North Wales Organisation for Randomised Trials in Health and Social Care (NWORTH):
NWORTH is a clinical trials unit (CTU) which has full UKCRC registration. The mission of the Unit is to conduct clinical trials and studies of complex interventions of the highest quality, delivering research with impact and advancing methodological developments in clinical trials research. With a history of successful design and delivery of pragmatic trials of complex interventions, NWORTH provides a wide range of research and development opportunities for its staff.

The post is to provide 9-months maternity cover for the current Quality Assurance Officer. As part of an established team working in the area of clinical trials, the postholder will ensure NWORTH Clinical Trials Unit is compliant with national and international standards for the conduct of health research including:
UK policy framework for health and social care research (2017), the World Medical Association Declaration of Helsinki (1996), Principles of ICH Good Clinical Practice, and the current regulatory requirements, as detailed in the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK S.I. 2004/1031) and subsequent amendments of the clinical trial regulations. The post holder will provide the QA insight into prospective new collaborations and feed these back to the core operational team at project triage.

• To provide specialist advice to NWORTH staff, collaborators and participating centres on national and international standards for the conduct of clinical research and to ensure that NWORTH is compliant.
• To maintain and develop the existing Quality Management System (QMS), to monitor compliance to UK regulations within NWORTH projects and update as and when necessary.
• To liaise with University’s Governance Services to support alignment of NWORTH QMS with the University’s Research Governance policies.

To be responsible for:

• Quality Assurance activities related to the clinical trial(s) managed by NWORTH and to ensure that relevant staff are fully aware of, trained in, and comply with trial regulations.
• To provide training as and when necessary, on Standard Operating Procedures (SOPs), quality and regulatory-related activities.
• To plan, develop and monitor the implementation of SOPs within NWORTH and, where appropriate, within individual trials.
• Manage the programme of review and update of existing SOPs to ensure continuing compliance with the UK regulations.
• Ensure implementation of SOPs, and any associated Work Instructions or Record Forms, as part of the CTU Quality Management System, including appropriate review, sign-off, and controlled distribution.
• Work closely with all staff to ensure that the requirements of the Quality Management System are fully incorporated within daily working practice. This will involve acting as the focus for provision of clear, consistent and timely information and advice to staff and researchers internally and externally in accordance with CTU SOPs and regulatory requirements.
• Determine audit schedules/plans and supervise a programme of regular system and documentation audits within the CTU to monitor adherence to SOPs and regulations. Maintain records of all audits and provide formal written feedback to the CTU Manager and other senior staff as appropriate and ensure execution of any necessary corrective action(s).
• Oversee risk assessments for all studies / trials in collaboration with the Principal/Chief Investigator(s) and monitoring compliance to monitoring plans.
• The systematic review of new trial protocols in collaboration with the NWORTH CTU Director and input into the decision-making process for the contracting of the CTU to support new trials.
• During protocol development provide advice to collaborators on the QA aspects of the study.
• To keep up to date with changes to the trial regulations and to disseminate and where appropriate implement the new/revised requirements.
• Prepare for inspections/audits by regulatory authorities such as Medicines and Healthcare products Regulatory Agency (MHRA) and audit NWORTH in preparation for such inspections.
• Determine, measure, and achieve quality performance targets. Establish efficient processes for collecting and analysing key quality metrics and identify, define, and implement improvements to the quality management system.
• Responsible for producing quality performance reports to the CTU Manager.
• Represent the CTU at meetings with internal and external collaborators and provide feedback on quality management issues.
• The QA Officer may line-manage members of staff directly and will have responsibility for other team members indirectly.
• Setting individual performance targets for the Quality Assurance Support Officer under the University’s performance development review (PDR) scheme.
• Monitoring performance of the Quality Assurance Support Officer in consultation with the CTU Manager.

• Motivate staff in the team to achieve the goals set as part of project plans; identifying individual non-performance or exceptional performance and establishing the necessary action plans to rectify deficiencies and reward potential, including drawing up individual training and development plans for staff members.

Other Duties and Responsibilities

• The post holder will be expected to participate in performance review and developmental activities.
• The post holder will be expected to comply with the University’s equality policies and statements, Dignity at Work and Study Policy and the University’s Welsh Language Scheme.
• The post holder has a general and legal duty of care in relation to health, safety and wellbeing and must take all reasonable steps to ensure a safe and healthy working environment for him/her self and for other members of staff, students and visitors affected by his/her actions or inactions. The post holder is also required to comply with all applicable health and safety policies, procedures, and risk assessments.
• The post holder must comply with relevant legal and financial policies and procedures and be aware of their responsibilities in terms of the legal requirements of their posts.

Qualifications/Training
Essential

• Postgraduate qualification in a relevant discipline or comparable experience in clinical trials.
• First degree in relevant discipline, e.g., science, law, business administration, health studies or equivalent experience in clinical trials.

Desirable 

• Member of a professional body with respect to Quality Assurance.
• Management or leadership qualification or equivalent experience.

Experience/Knowledge
Essential

• Clinical research governance experience – including non-commercial, contract research organisation or pharmaceutical company.
• Experience of developing standard operating procedures (SOPs).
• Experience of monitoring and auditing research projects in an NHS Trust and/or Higher Education Institution (HEI) environment.
• Experience of clinical trials / health research quality assurance.
• Experience of working with staff from a range of different professional backgrounds and varying levels of seniority.
• Experience of writing up detailed, concise reports for monitoring and/or audit visits for research projects.
• Experience of training clinical and non-clinical staff in clinical trial research governance.
• Thorough knowledge of The Medicines for Human Use (Clinical Trials) Regulations (2004) including subsequent amendments, the UK policy framework for health and social care research, (2017), and Good Clinical Practice.

Desirable 

• Project Management qualification or experience.
• Mentoring qualification or experience.

Skills/Abilities
Essential

• Excellent communication skills – both verbal and written – and the ability to communicate effectively with a wide range of internal and external collaborators.
• Ability to work in a fast-paced environment, identify priorities, initiate action, take forward multiple tasks and work independently.
• Excellent interpersonal skills and willingness to work collaboratively with others, (e.g., clinicians, trialists).
• Meticulous eye for detail.
• Ability to work with NHS Health Board collaborators and an understanding of the demands on them in relation to supporting coordinated research activities.
• Able and willing to work under pressure of deadlines, demonstrating a flexible attitude to work.
• Demonstrable IT skills including word processing, spreadsheets, databases and literature searching.
• Skilled trouble-shooter, with a decisive solution-focused approach.

Desirable

• Evidence of successful external networking and profile-raising.
• Evidence of disseminating own “good practice” effectively to others and taking up of “good practice” from other sources.

Other
Essential

• Willingness to occasionally travel within the UK.

Desirable 

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

The University is committed to supporting and promoting equality and diversity and to creating an inclusive working environment. We believe this can be achieved through attracting, developing, and retaining a diverse range of staff from many different backgrounds.  We strive to develop a workforce from all sections of the community regardless of sex, gender identity, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age. We promote and facilitate the use of the Welsh language through our progressive Welsh Language Policy. We comply with the Welsh Language Standards and are committed to equality of opportunity. You are welcome to apply for any job in English or Welsh and all applications submitted will be treated equally. 

We are a member of Advance HE's Athena SWAN Gender Equality charter and hold a Silver award in recognition of our commitment to and progress towards gender equality within the University's policies, practices, and culture. We are proud to be a Disability Confident employer. 

All members of staff have a duty to ensure their actions are in line with the overall environmental aims of the University and minimise their environmental impact. 

All offers are made subject to proof of eligibility to work in the UK and receipt of satisfactory references.  

We have a legal responsibility to ensure that you have the right to work in the UK before you can start working for us.  When you apply for this post you will be required to explain the basis upon which you believe you will able to live and work in the UK legally on the commencement date of the role should your application be successful.   If you do not have the right to work freely in any position in the UK already, any offer of employment we will make to you will be subject to you obtaining a right to work visa.   The following link provides information on the various visa routes into employment and the eligibility requirements (including switching visa status where permissible) https://www.gov.uk/browse/visas-immigration/work-visas .   If you are successful in your application we will discuss visa options with you at the time of making the offer of employment.      

Please note that, in the event of applications being received from candidates on the University's Redeployment Register with a reasonable skills match to the post specification, these applicants will be given prior consideration.