Internal Applicants Only - Quality Assurance Officer

Internal Applicants Only - Quality Assurance Officer (Part-Time) Centre for Trials Research (CTR) College of Biomedical & Life Sciences The Centre for Trials Research at Cardiff University is a large, multinational community of researchers, professional services staff and students from a diverse range of backgrounds. We tackle the big diseases and health concerns of our time by forming partnerships with researchers and building lasting relationships with the public. Find out more about the Centre and working with us here. The Centre for Trials Research (CTR) at Cardiff University is the largest group of academic clinical trials staff in Wales, and has earned full UK Clinical Research Collaboration (UKCRC) registered status. The Centre tackles the big diseases and health concerns of our time, including growing resistance to antibiotics, early cancer diagnosis and how to eliminate health inequalities. It achieves this by forming partnerships with researchers and building lasting relationships with the public, whose participation is essential for the success of studies. You will support the Centre with Quality Assurance and Regulatory Affairs (QA & RA) work providing advice, guidance and training and developing and leading on projects within QA & RA. You will undertake the review of clinical trial documentation (e.g. protocols, case report forms, database specifications and user acceptance testing) and will collaborate with others to make recommendations for improvements on established processes and procedures. You will undertake administrative duties including the use and administration of Q-Pulse, the Centre's Quality Management system and will provide training to centre staff on its use. You will assist the Head of QA & RA with oversight of mandatory learning and development activities and clinical trials archiving processes. You will also facilitate the Centre's Audit programme and will be asked to conduct audit related activities., Support the Centre with Quality Assurance and Regulatory Affairs' (QA & RA) work, carrying out supporting work, providing advice, guidance and training and developing and leading projects within this area,

• Provide professional advice and guidance on QA & RA processes and procedures to internal and external customers, using judgement and creativity to suggest the most appropriate course of action where appropriate, and ensuring complex and conceptual issues are understood
• Investigate and analysis specific issues within QA of clinical trials data and documents, creating recommendation reports, supported by advances within QA & RA
• Ensure that the provision of QA & RA is delivered to the centre, proactively changing the delivery according to customer requirements
• Collaborate with others in order to make recommendations for developments of established protocols, processes and procedures
• Establish working relationships with key contacts, developing appropriate communication links with the University's Schools/Directorates and outside bodies as required
• Create specific working groups from colleagues across the Centre and University to achieve Centre objectives
• Supervise specific project teams on an occasional basis to accomplish key objectives
• Develop and deliver training within QA & RA
• To engage in more general Quality Assurance work as appropriate
• Undertake a variety of QA & RA administrative duties to support the Centre
• Instruct and guide other employees across the Centre and University within QA & RA as required
• Ensure that work is undertaken and documented in a regulatory compliant way and be prepared for regular audits and inspections, as well as contributing to the development of the Quality management system for the area of QA & RA
General Duties
• Ensure that an understanding of the importance of confidentiality is applied when undertaking all duties
• Abide by University policies on Health and Safety and Equality and Diversity
• Perform other duties occasionally which are not included above, but which will be consistent with the role
  
  Candidates should hold a degree/NVQ4 or equivalent professional membership or have experience of working in a clinical trials or research environment with demonstrable Quality Assurance or regulatory affairs experience. Candidates should have the ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people and be able to solve expansive problems using initiative and creativity. Experience of undertaking audits or quality reviews of trials documentation would be advantageous.
With a culture of continuous professional and career development the Centre has an excellent track record of helping people develop in their areas of interest, with many progressing within the Centre itself, the wider University or further afield., Qualifications and Education 1. Degree/NVQ 4 or equivalent Professional membership/experience Knowledge, Skills and Experience 2. Substantial experience of working within a research or trials environment with demonstrable quality assurance or regulatory affairs experience 3. Able to demonstrate professional knowledge within QA & RA, to give advice and guidance to internal and external customers 4. Ability to set up standard office systems and procedures and make improvements as appropriate Customer Service, Communication and Team Working 5. Ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people 6. Evidence of ability to explore customers' needs and adapt the service accordingly to ensure a quality service is delivered Planning, Analysis and Problem solving 7. Evidence of ability to solve expansive problems using initiative and creativity; identify and proposing practical solutions and resolving problems with a range of potential outcomes 8. Evidence of demonstrable knowledge of key advances within QA & RA 9. Evidence of ability to work unsupervised to deadlines, planning and setting priorities for own work and that of others and monitoring progress Other 10. A willingness to undertake further training and development, 11. Experience of working in industry 12. Postgraduate/Professional qualification 13. Experience of undertaking audit or quality reviews of trials documentation 14. Fluency in Welsh, written and oral

Cardiff 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 therefore welcome applicants from all sections of the community regardless of sex, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age. In supporting our employees to achieve a balance between their work and their personal lives, we will also consider proposals for flexible working or job share arrangements., Applications may be submitted in Welsh, and an application submitted in Welsh will not be treated less favourably than an application submitted in English.

This post is part-time (25 hours per week), fixed-term for 12 months, based at Heath Park and is available immediately. The majority of roles at Cardiff University are currently operating under "blended working" arrangements, with staff having the flexibility to work partly from home and partly from the University campus depending on specific business requirements. Discussions around these arrangements can take place after the successful candidate has been appointed. Salary: £32,332 - £34,980 per annum, pro rata (Grade 5). Appointments to roles at Cardiff University are usually made at bottom of scale unless in exceptional circumstances. Cardiff University offers many excellent benefits, including 45 days annual leave pro rata (incl. bank holidays), local pension scheme, a cycle to work scheme and other travel initiatives, annual increments within the pay scale, and more. It's an exciting and vibrant place to work with many different challenges and is a proud Living Wage supporter. Business needs will require some degree of office-based working but the balance of time can be spent in the office or remotely (subject to agreement with the line manager).