Description Position Details College of Medicine and Health Location: University of Birmingham, Edgbaston, Birmingham UK Full time starting salary is normally in the range £36,130 to £45,413 with potential progression once in post to £48,149 Grade: 7 Part Time (22.5 hours per week) Permanent Closing date: 1st April 2025 UK and International travel may be required for this role Are you considering a career at the University of Birmingham? Our Recruitment Team is hosting one-to-one conversations to help you understand the application process, provide updates on existing applications, and answer general questions about working at the University. Our next appointments are available on Friday 28th March; click here to book. Further dates and opportunities to connect with us in person will be advertised on future job listings. Our offer to you People are at the heart of what we are and do. The University of Birmingham is proud to have been a part of the City of Birmingham and the wider region for over 100 years, and we are equally proud to be recognised as a leading global university. We want to attract talented people from across the city and beyond, support them to succeed, and celebrate their success. We are committed to helping the people who work here to develop through our sector-leading Birmingham Professional programme which provides all professional services staff with development opportunities and the encouragement to reach their full potential. With almost 5,000 professional services jobs in a wide-range of functions in Edgbaston and in our campus in Dubai, there are plenty of opportunities for you to be able to develop your career at the University. We believe there is no such thing as a typical member of staff and that diversity is a source of strength that underpins the exchange of ideas, innovation, and debate. We warmly welcome people from all backgrounds and are committed to fostering an inclusive environment where diversity is at the heart of who and what we are, and how we work. Supporting our people to achieve a healthy work/life balance is important both to our employees and to the success of the University and, depending on the role, we offer a variety of flexible working arrangements. We therefore welcome discussions on all forms of flexible working. In addition, you will receive a generous package of benefits including 40 days paid holiday a year, one paid day a year for volunteering, occupational sick pay, and a pension scheme. We also have three high quality subsidised day nurseries. The University is situated in leafy Edgbaston and there are excellent transport links to our beautiful campus, including main bus routes and a train station on site. On campus we have a state-of-the-art sports centre with pool, shops, places to eat and drink, our own art gallery, museum and botanical gardens. Find out more about the benefits of working for the University of Birmingham Background With its broad portfolio of clinical trials and clinical studies, the UOB is one of the leading centres for clinical research in the UK. In its role as a sponsor/hosting institution for clinical research, the UOB has set up an infrastructure to maintain appropriate oversight, consisting of committees, groups and teams who are fully committed to delivering high-quality clinical research. Within the College of Medicine and Health, the Clinical Research Compliance Team (CRCT) is responsible for ensuring researchers within the University are provided with tools, training and compliance checks that will help the researchers, and the University at large, to meet the applicable standards and regulations. The CRCT work closely with the Research Ethics, Governance & Integrity Team (REGI) that are responsible for coordinating the University’s internal ethical review processes and acts as the University’ sponsor representative. The CRCT also provide support to the University’s two UK clinical research collaboration (UKCRC)-registered specialist clinical trials units; Birmingham Clinical Trials Unit (BCTU) and Cancer Research UK Clinical Trials Unit (CRCTU). In addition, the CRCT provides support and oversight of the clinical research related laboratories and University’s licensed tissue bank facilities (including the Human Biomaterials Resource Centre (HBRC) ) and Medicines Manufacturing Facility (MMF). Role Summary As a Senior QA Officer, you will provide specialist advice and support to ensure predefined standards, policies, procedures, frameworks, and legislation are upheld. You will also deliver to the development and maintenance of relevant quality management systems (QMSs), compliance review programmes (e.g. audits, monitoring, quality checks) and training programmes. For the flexibility of the wider team, you may be asked to work in a clinical research quality team elsewhere in the department or across the wider University. Ability to travel in the UK and internationally on occasion. Overnight stays between visits may be required occasionally and on occasion trips may include longer stays. Main Duties Support the delivery of clinical research in accordance with standards and regulations, to protect research participants and data integrity. This may include some or all of the following activities listed below. Providing specialist advice relating to regulatory compliance queries. Reviewing key study/trial documents and providing feedback. Developing and proposing solutions for any issues identified. Preparing and delivering training (e.g., for staff inductions, workshops, lectures, tutorials). Assessing and escalating issues and risks as appropriate (e.g., serious breaches, suspicion of fraud or misbehaviour). Recommending and contributing to improvements in governance/compliance processes. Managing a defined area of quality/compliance (e.g., an audit programme) and ensuring that the area is fit for purpose and delivering as required. Sharing of best practices. Provide support to the development and maintenance of one or more QMSs within set timeframes. This may include some or all of the following activities listed below. Taking responsibility for developing and updating policies, standard operating procedures (SOPs) and tools within the system. Reviewing documentation to ensure the University meets all applicable regulatory requirements. Reporting on progress, including the development of reporting mechanisms, writing reports (e.g. on proposed changes), and presenting to appropriate meetings such as oversight committees or to other key stakeholders. Delivering training on QMS topics as required. Stakeholder management, ensuring effective liaison with (for example) researchers, managers, topic leads as appropriate. Responsible for planning and conducting internal and external compliance visits (e.g., audits, monitoring, quality checks) as appropriate. Maintain an up-to-date knowledge of legal and regulatory requirements, and accepted quality standards for clinical research. The regulations and standards may include but are not limited to those listed below. The Medicines for Human Use Clinical Trials Regulations, Data Protection Act, Human Tissue Act. Good Clinical Practice (GCP), GCP in the Laboratory and Good Manufacturing Practices (GMP). The Declaration of Helsinki. UK Policy Framework for Health and Social Care Research. Caldicott Principals. University policies and procedures, including, but not limited to the UoB Data Protection Policy, Information Security Policy and Code of Practice for Research. Contribute to the organisation and delivery of inspections/ conferences/ meetings/ workshops if required. Promotes equality and values diversity acting as a role model and fostering an inclusive working culture. Supports the University’s sustainability agenda through resource efficient working. Any other duties commensurate with the grade. Required Knowledge, Skills, Qualifications, Experience Qualified to Degree level (or equivalent) in a relevant biomedical or associated subject plus a significant experience working in clinical research, or substantial relevant experience evidencing the experience required in this role. Proven knowledge of the legal and regulatory framework that governs clinical research. Shown experience in developing and/or maintaining quality management systems. Excellent interpersonal, communication, relationship building and influencing skills with the ability to deal confidently with a range of internal and external stakeholders/contacts. Ability to work on own initiative and problem solve. Excellent organisational and multi-tasking skills with a methodical approach to work and the ability to prioritise workloads in order to meet deadlines. Demonstrate a critical and intelligent attention to detail and high standards of accuracy. Highly proficient IT skills, including the MS Office. You should be confident and able to quickly learn new IT skills and software packages as required. Ability to travel in the UK and internationally on occasion. Overnight stays between visits may be required occasionally and on occasion trips may include longer stays. Knowledge of the protected characteristics of the Equality Act 2010, and how to actively ensure in day-to-day activity in own area that those with protected characteristics are treated equally and fairly. Dimensions Roles at this level will require a broad understanding and practical experience of an administrative or professional field which will be used to plan the running and development of services and/or lead shorter term projects or contribute to larger projects. You will work with information which needs interpretation and analysis; you will use your judgement to identify the best solution to differing problems and issues, offering recommendations for managing more complex situations. You will likely need to liaise and/or co-ordinate activities across a number of different sections within the department or possibly with wider department or external bodies as appropriate. You may also be responsible for managing a team of staff, being accountable for recruiting and developing them and for managing performance. Planning and Organising plan the running and development of project(s)/service(s), overseeing resources and inputting into resource planning as appropriate; develop, agree and implement standards for delivery for own area; manage a team of staff and review, develop and motivate them; plan relevant training and development; provide professional advice, guidance and support to others within and outside their immediate work area; oversee resources and make recommendations about future resource requirements. Problem Solving and decision making review, develop and propose solutions for problems with (for example) staff, budgets, services and/or systems; deal effectively with unexpected issues, such as changing priorities; deal with sensitive people matters/issues; provide specialist advice and recommendations to support decision–making of others. Internal and External relationships understand their own and closely-related working areas and how they contribute to the success of the University. has an understanding of how the University operates; actively seeks to share this knowledge with others. developing empathy with the academic endeavour. influence decision makers and win support for proposals; develop excellent working relationships within and outside of own area and potentially with external stakeholders; co-ordinate activities across a number of areas. Further particulars can be found here Informal enquiries to Jamie Douglas-Pugh, email: J.K.Douglas-Pughbham.ac.uk View our staff values and behaviours here We believe there is no such thing as a 'typical' member of University of Birmingham staff and that diversity in its many forms is a strength that underpins the exchange of ideas, innovation and debate at the heart of University life. We are committed to proactively addressing the barriers experienced by some groups in our community and are proud to hold Athena SWAN, Race Equality Charter and Disability Confident accreditations. We have an Equality Diversity and Inclusion Centre that focuses on continuously improving the University as a fair and inclusive place to work where everyone has the opportunity to succeed. We are also committed to sustainability, which is a key part of our strategy. You can find out more about our work to create a fairer university for everyone on our website .