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The University of Oxford is a stimulating work environment, which enjoys an international reputation as a world-class centre of excellence. Research Services is one of the key Professional Services Department supporting Oxford’s research and innovation community. Our values include teamwork, professionalism, continuous improvement, empathy, respect and trust. The Research Governance, Ethics and Assurance Team (RGEA) provides expert advice and guidance on regulatory and compliance matters in relation to research involving human participants and acts as the Sponsor Office for clinical research conducted in the UK and overseas. As a member of the Joint Research Office, RGEA works in collaboration with Oxford University Hospitals NHS Foundation Trust, Oxford Health NHS Foundation Trust, and Oxford Brookes University. We have an exciting opportunity to join the Research Services Department as a Clinical Research Support Lead in the RGEA Team. What We Offer As an employer, we genuinely care about our employees’ wellbeing and this is reflected in the range of benefits that we offer including: • An excellent contributory pension scheme • 38 days annual leave • A comprehensive range of childcare services • Family leave schemes • Cycle loan scheme • Discounted bus travel and Season Ticket travel loans • Membership to a variety of social and sports clubs This role also offers the opportunity for hybrid working, with a current expectation of at least 50% on-site work. About the Role This senior position within RGEA works alongside other RGEA Leads and is focussed on leading an operationally effective and expert service for clinical research sponsorship activities on behalf of the University of Oxford, including sponsorship review and authorisation, on-going oversight of compliance and providing support, guidance and training for academics, researchers, and research support professionals. You will work closely with researchers, research support staff and administrators across the University, including University departments and Clinical Trials Units, and with colleagues in the Joint Research Office, and external organisations (including the Health Research Authority (HRA), NHS RECs and the MHRA), to ensure that the University complies with applicable regulations and guidelines, whilst minimising the bureaucratic burden on researchers. About You To be successful in this wide-ranging and stimulating role, you will need to be someone who strives for excellence and enjoys providing high quality customer service. You will have extensive working knowledge of relevant legislation, GCP and HRA/NHS REC/MHRA policies and procedures. You will have great communication skills, and be confident in the ability to communicate to members of the public, students, and academic staff with courtesy and politeness. You will also have a positive attitude, be an exceptional line manager with an adaptable approach to your work, think innovatively when responding to changes in the clinical research governance landscape, and be comfortable when priorities suddenly need to change. RGEA works as an open, collaborative team, so an enthusiasm and ability to lead with others as a team player, to contribute to collective leadership, planning, and continuous improvement of the department overall, and actively championing our values and commitments will be essential. Application Process You will be required to upload a covering letter/supporting statement, CV and the details of two referees as part of your online application. If you would like to discuss this position, please contact Dr Ferdousi Chowdhury, (ferdousi.chowdhury@admin.ox.ac.uk). The closing date for applications is 12 noon on 29th July 2024. Interviews are anticipated to take place on week commencing 5th August 2024
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173985 Clinical Research Support Lead JD.pdf
_________________________________________________________________________ RESEARCH SERVICES Summary Job title Clinical Research Support Lead Division University Administration and Services Department Research Services Location Joint Research Office, Boundary Brook House, Churchill Drive, Headington, Oxford, OX3 7GB Grade and salary Grade 9: £52,815 - £61,198 Hours Full time or part time (minimum 80%FTE) Contract type Permanent Reporting to Assistant Director/Director, Research Governance, Ethics & Assurance Vacancy reference 173985 Additional information The role This is a critical position within the Research Governance, Ethics & Assurance team (RGEA) focussed on providing support and guidance for research support professionals as they carry out research sponsorship reviews and advise researchers on clinical research governance throughout the University. This includes sponsorship reviews for submissions to NHS research ethics committees, the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA)and oversight activities to ensure compliance with relevant policies and regulations. This role also works closely with the RGEA ethics group on projects that require University ethics approval and HRA approvals. The post-holder will have joint responsibility with other RGEA Leads for the harmonisation of procedures in relation to the business activities supporting research involving human participants, wherever this is possible. Responsibilities Management 1. Proactively contribute to planning and strategy discussions as part of the senior management team of the group, working with the Assistant/Director and other Leads, to ensure that the management of the team overall is cohesive and effective. Provide support for the Director/Assistant Director of RGEA, deputising for them where required. 2. Lead, manage and support the work of Research Support professionals including through line-management of a number of Grade 8/Grade 7 staff. Set overall goals for the group, maintaining a clear oversight and having accountability for service delivery. Act as the escalation point for queries or concerns raised within the group, taking an open and transparent approach with other Leads, Assistant Director and Director, to ensure appropriate resolution. 3. Provide clear and comprehensive reports on the processes, operations and performance of the group, and work closely with other RGEA Leads, using a continuous improvement approach, to identify ways in which these can be improved and harmonised with other functions. Support the Assistant Director and Director to analyse and report on key performance indicators of research approvals. 4. Establish clear processes for the oversight of workloads and service delivery timelines, the experience and training needs of members of the group, ensuring competency and knowledge development and diversity of experience to deliver in their roles; aligning these with the needs of the RGEA team overall. Display a commitment to promotion of Research Services’ shared culture and values. 5. Proactively contribute and participate, and encourage reportees to contribute and participate, to cross-working groups and opportunities within Research Services. Sponsorship review 6. On behalf of the University as Research Sponsor, take responsibility for the authorisation of research studies and trials, both in the initial application and for subsequent amendments. Maintain oversight of sponsorship reviews carried out by the RGEA team and the applications process and provide guidance and advice to members of the team where required. 7. Provide expert advice to University researchers, study teams and departments and research support staff, including those in RGEA, in line with RGEA agreed positions, on matters relating to clinical research governance and sponsorship requirements, ensuring appropriate discussions and escalation within RGEA as required. 8. Develop Standard Operating Procedures and other guidance related to the approval, sponsorship, amendments and the ongoing oversight of studies. This includes promoting compliance with the UK Policy Framework for Health & Social Care Research 2017; Medicines for Human Use (Clinical Trials) Regulations 2004 and amendments; Guidelines for Good Clinical Practice (GCP); Human Tissue Act 2004; Mental Capacity Act 2005; UK General Data Protection Regulation. 2 9. Working with the Assistant/Director, establish and maintain a risk-based approach for identifying levels of risk and complexity and establish appropriate parameters for review and escalation. 10. Develop and oversee compliance check and audit processes for sponsored studies, identifying areas of risk and trends in areas of both good practice and poor compliance. Consider strategies for both addressing trends and communication of learning across Univeristy research groups. Where appropriate, establish and oversee corrective and preventative action plans (CAPA) to address non-compliances, working with the QA group for advice and guidance and OUH R&D colleagues to align processes. 11. Establish, develop and maintain strong collaborative links, including across RS; with JRO colleagues; the HRA; and other national networks, to maintain current awareness of the local, national and international research landscape, ensuring that developments are appropriately disseminated and assessed within the RGEA team and take responsibility with other Leads to ensure existing processes are amended in an appropriate timeframe as required. 12. Work with the Operations & Training lead to identify the need for new or updated content for the RGEA web pages, ensuring that this remains current, clear and appropriate and enables convenient access to information relevant for compliance with the regulations. 13. Participate in the development, maintenance, continual review and improvement of systems to ensure that studies reviewed for sponsorship are compliant with the relevant legislation and ethical requirements. Identify opportunities for improvement in the current systems and processes; followed by provision of training of the team and assistance to address them and improve performance. Provision of training 14. Through collaboration with the Operations & Training Lead and other senior managers, contribute to the ongoing development, organisation and delivery of formal training for researchers at all levels, research support staff and students. Design and deliver bespoke training for departments as demand arises. Through collaboration with colleagues in the Joint Research Office, extend joint provision of training to clinical researchers in the Oxford University Hospitals NHS Trust. 15. Facilitate communication between the research teams to enable sharing of best practice with the objective of improving the general quality and compliance level within the University. Mentor and train new researchers on good practice in research, the regulations, ethics applications and other research related issues. As Required 16. Play a leading role, on behalf of the University, in external networks and engagement with regulatory bodies in all areas relevant to the role, as agreed with Assistant/Director and other Leads. 17. Undertake other duties as required by the Director/Assistant Director of RGA or other senior officers of the University. 3 Selection criteria The person appointed must demonstrate that they have: 1. Substantial knowledge and expertise in clinical research, with a breadth of experience of engaging with the range of organisational and individual roles involved in contributing to sound research governance in a non-commercial Sponsor setting. 2. Exceptional knowledge and experience of the regulatory and ethical frameworks for the governance of regulatory (CTIMPs/Medical Device studies) and non-regulatory clinical research and a demonstrable understanding of their application in a non-commercial environment. This includes the UK Policy Framework for Health & Social Care Research 2017; Medicines for Human Use (Clinical Trials) Regulations 2004 and amendments; Guidelines for Good Clinical Practice (GCP); Human Tissue Act 2004; Mental Capacity Act 2005; UK General Data Protection Regulation. 3. Evidence of leadership qualities and strong interpersonal skills, as well as the ability to work constructively as part of a close-knit team and provide training and mentoring as required. Demonstrated experience of staff management, supporting colleagues to succeed and a commitment to promoting equality, diversity and inclusion. 4. A strong customer service ethos with experience in leading high-performing customer-facing teams and tracking and improving service performance. 5. Excellent communication and listening skills, as well as a sharp analytical mind, an ability to think laterally and grasp complex and sensitive issues, using innovative thought and a solution orientated approach. 6. Proven experience of working constructively with a diverse range of stakeholders, including senior managers within both academic and industry environments and high profile individuals within national and international organisations. Credibility with the academic community and external stakeholders and the ability to represent Research Services and the University at a senior level. 7. Adaptive approach to work. An organised approach to dealing with large numbers of complex documents and an ability to think on one’s feet under pressure. 8. A strong interest in teaching, training and mentoring of adults in a clinical research environment, with a confident and enthusiastic ability to deliver training. 9. Enthusiasm for implementing change and the ability to bring fresh thinking to research processes enabling the team to develop and improve their systems. 10. Extensive experience dealing with typically complex, sensitive issues related to research governance, ethics and compliance, including providing case-specific advice where there is a lack of precedent, requiring innovative thought to develop appropriate solutions. 11. The ability to work on policy advice and experience of drafting guidance, papers and reports. 4 Pre-employment screening Standard checks If you are offered the post, the offer will be subject to standard pre-employment checks. You will be asked to provide: proof of your right-to-work in the UK; proof of your identity; and (if we haven’t done so already) we will contact the referees you have nominated. You will also be asked to complete a health declaration so that you can tell us about any health conditions or disabilities for which you may need us to make appropriate adjustments. Please read the candidate notes on the University’s pre-employment screening procedures at: https://www.jobs.ox.ac.uk/pre-employment-checks About the University of Oxford Welcome to the University of Oxford. We aim to lead the world in research and education for the benefit of society both in the UK and globally. Oxford’s researchers engage with academic, commercial and cultural partners across the world to stimulate high-quality research and enable innovation through a broad range of social, policy and economic impacts. We believe our strengths lie both in empowering individuals and teams to address fundamental questions of global significance, while providing all our staff with a welcoming and inclusive workplace that enables everyone to develop and do their best work. Recognising that diversity is our strength, vital for innovation and creativity, we aspire to build a truly diverse community which values and respects every individual’s unique contribution. While we have long traditions of scholarship, we are also forward-looking, creative and cuttingedge. Oxford is one of Europe's most entrepreneurial universities and we rank first in the UK for university spin-outs, and in recent years we have spun out 15-20 new companies every year. We are also recognised as leaders in support for social enterprise. Join us and you will find a unique, democratic and international community, a great range of staff benefits and access to a vibrant array of cultural activities in the beautiful city of Oxford. For more information, please visit www.ox.ac.uk/about/organisation. University Administration and Services University Administration and Services (UAS) is the collective term for the central administrative departments of the University. UAS comprises structures to:    support the University’s core academic purposes of teaching, learning and research; ensure the University can meet the requirements of government, funding bodies and other external agencies; and facilitate the attainment of the objectives set out in the University’s Strategic Plan. The offices of the UAS sections are spread across the city, with the main University Offices located in Wellington Square. For more information please visit: http://www.admin.ox.ac.uk/ 5 Department: Research Services Research Services is part of UAS and works in partnership with the academic divisions and their departments and faculties to support Oxford’s researchers. Our role is to facilitate excellence in research, engagement and innovation at Oxford. Our vision is to be a trusted provider of expertise, strategic insight, internal and external influence and excellent professional support to Oxford’s research, engagement and innovation community. Research Services is a large team of over 140 research support professionals, with a wideranging remit including: - Supporting the acquisition of external research funding, funder engagement and strategic research initiatives comprehensive funding, contracts and research development support Negotiating research-related contracts Supporting institutional research strategy, policy and planning Facilitating knowledge exchange, innovation and engagement and coordinating the development and delivery of knowledge exchange strategy and policy Promoting the responsible conduct of research and compliance with regulatory and research governance requirements Leading the continuous improvement of research administration at Oxford Our values and commitments govern the way we work with others within Research Services, the University and externally, including our commitment to professionalism, consultation, teamwork and continuous improvement. You can read more about our values and commitments here. Further information about Research Services can be found on our website researchsupport.admin.ox.ac.uk. Oxford secures more external funding for research than any other UK institution (£634m in 2019/20). This research creates novel issues from an insurance perspective: autonomous vehicles being driven on public roads; adding equipment to space satellites worth over £50m; undertaking studies in refugee camps in some of the most challenging regions of the world; sponsoring clinical trials in over 60 countries. The University sponsors more clinical trials and clinical studies than any other academic institution in the UK and probably Europe. These range from Phase 1 trials on healthy volunteers – often using clinical agents manufactured by the University itself – through to Phase 4 trials into which tens of thousands of patients are recruited world-wide. Research Governance, Ethics & Assurance Team This team provides support and policy around research involving human participants; both clinical and non-clinical; and including the use of human tissue and personal data. Our aim is to encourage research which protect the rights, dignity, safety and wellbeing of participants, researchers and research users, through the provision of expertise, training, guidance materials and support to academics undertaking research. We facilitate compliance and assurance with internal and external policy, standards and regulatory frameworks. The team supports submissions to internal and external research ethics committees and represents the University as research sponsor of clinical research. We advise on risk management in research, including provision of specialist research insurance services. Joint Research Office The JRO is a partnership between the University of Oxford (OU) and Oxford University Hospitals NHS Foundation Trust (OUH); Oxford Health NHS Foundation Trust and Oxford Brookes University. The world-leading medical and healthcare-related research conducted by JRO teams 6 combines clinical and academic expertise with state-of-the-art facilities and is dependent on the provision of effective support services by the JRO to translate discovery into patient benefit. The JRO’s specialist teams provide expert research support throughout the study life-cycle across a broad spectrum of areas. These include grant applications and pre-set up, through to contract and commercialisation expertise, communications advice and study closure. How to apply Applications are made through our e-recruitment system and you will find all the information you need about how to apply on our Jobs website https://www.jobs.ox.ac.uk/how-to-apply. Your application will be judged solely on the basis of how you demonstrate that you meet the selection criteria stated in the job description. As part of your application you will be asked to provide details of two referees and indicate whether we can contact them now. You will be asked to upload a CV and a supporting statement. The supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience. This may include experience gained in employment, education, or during career breaks (such as time out to care for dependants) Please upload all documents as PDF files with your name and the document type in the filename. All applications must be received by midday UK time on the closing date stated in the online advertisement. Information for priority candidates A priority candidate is a University employee who is seeking redeployment because they have been advised that they are at risk of redundancy, or on grounds of ill-health/disability. Priority candidates are issued with a redeployment letter by their employing department(s). If you are a priority candidate, please ensure that you attach your redeployment letter to your application (or email it to the contact address on the advert if the application form used for the vacancy does not allow attachments). If you need help Help and support is available from: https://hrsystems.admin.ox.ac.uk/recruitment-support If you require any further assistance please email recruitment.support@admin.ox.ac.uk. To return to the online application at any stage, please go to: www.recruit.ox.ac.uk. Please note that you will receive an automated email from our e-recruitment system to confirm receipt of your application. Please check your spam/junk mail if you do not receive this email. Important information for candidates Data Privacy 7 Please note that any personal data submitted to the University as part of the job application process will be processed in accordance with the GDPR and related UK data protection legislation. For further information, please see the University’s Privacy Notice for Job Applicants at: https://compliance.admin.ox.ac.uk/job-applicant-privacy-policy. The University’s Policy on Data Protection is available at: https://compliance.admin.ox.ac.uk/data-protection-policy. The University’s policy on retirement The University operates an Employer Justified Retirement Age (EJRA) for all academic posts and some academic-related posts. The University has adopted an EJRA of 30 September before the 69th birthday for all academic and academic-related staff in posts at grade 8 and above. The justification for this is explained at: https://hr.admin.ox.ac.uk/the-ejra For existing employees, any employment beyond the retirement age is subject to approval through the procedures: https://hr.admin.ox.ac.uk/the-ejra There is no normal or fixed age at which staff in posts at grades 1–7 have to retire. Staff at these grades may elect to retire in accordance with the rules of the applicable pension scheme, as may be amended from time to time. Equality of opportunity Entry into employment with the University and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular post and the relevant salary structure. In all cases, ability to perform the job will be the primary consideration. No applicant or member of staff shall be discriminated against because of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation. 8 Benefits of working at the University Employee benefits University employees enjoy 38 days’ paid holiday, generous pension schemes, travel discounts, and a variety of professional development opportunities. Our range of other employee benefits and discounts also includes free entry to the Botanic Gardens and University colleges, and discounts at University museums. See https://hr.admin.ox.ac.uk/staff-benefits University Club and sports facilities Membership of the University Club is free for all University staff. The University Club offers social, sporting, and hospitality facilities. Staff can also use the University Sports Centre on Iffley Road at discounted rates, including a fitness centre, powerlifting room, and swimming pool. See www.club.ox.ac.uk and https://www.sport.ox.ac.uk/. Information for staff new to Oxford If you are relocating to Oxfordshire from overseas or elsewhere in the UK, the University's Welcome Service website includes practical information about settling in the area, including advice on relocation, accommodation, and local schools. See https://welcome.ox.ac.uk/ There is also a visa loan scheme to cover the costs of UK visa applications for staff and their dependents. See https://staffimmigration.admin.ox.ac.uk/visa-loan-scheme Family-friendly benefits With one of the most generous family leave schemes in the Higher Education sector, and a range of flexible working options, Oxford aims to be a family-friendly employer. We also subscribe to the Work+Family Space, a service that provides practical advice and support for employees who have caring responsibilities. The service offers a free telephone advice line, and the ability to book emergency back-up care for children, adult dependents and elderly relatives. See https://hr.admin.ox.ac.uk/my-family-care Childcare The University has excellent childcare services, including five University nurseries as well as University-supported places at many other private nurseries. For full details, including how to apply and the costs, see https://childcare.admin.ox.ac.uk/ Disabled staff We are committed to supporting members of staff with disabilities or long-term health conditions. For further details, including information about how to make contact, in confidence, with the University’s Staff Disability Advisor, see https://edu.admin.ox.ac.uk/disability-support Staff networks The University has a number of staff networks including the Oxford Research Staff Society, BME staff network, LGBT+ staff network and a disabled staff network. You can find more information at https://edu.admin.ox.ac.uk/networks The University of Oxford Newcomers' Club The University of Oxford Newcomers' Club is an organisation run by volunteers that aims to assist the partners of new staff settle into Oxford, and provides them with an opportunity to meet people and make connections in the local area. See www.newcomers.ox.ac.uk 9
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The University of Oxford is a stimulating work environment, which enjoys an international reputation as a world-class centre of excellence. Research Services is one of the key Professional Services Department supporting Oxford’s research and innovation community. Our values include teamwork, professionalism, continuous improvement, empathy, respect and trust. The Research Governance, Ethics and Assurance Team (RGEA) provides expert advice and guidance on regulatory and compliance matters in relation to research involving human participants and acts as the Sponsor Office for clinical research conducted in the UK and overseas. As a member of the Joint Research Office, RGEA works in collaboration with Oxford University Hospitals NHS Foundation Trust, Oxford Health NHS Foundation Trust, and Oxford Brookes University. We have an exciting opportunity to join the Research Services Department as a Clinical Research Support Lead in the RGEA Team. **What We Offer** As an employer, we genuinely care about our employees’ wellbeing and this is reflected in the range of benefits that we offer including: • An excellent contributory pension scheme • 38 days annual leave • A comprehensive range of childcare services • Family leave schemes • Cycle loan scheme • Discounted bus travel and Season Ticket travel loans • Membership to a variety of social and sports clubs This role also offers the opportunity for hybrid working, with a current expectation of at least 50% on-site work. **About the Role** This senior position within RGEA works alongside other RGEA Leads and is focussed on leading an operationally effective and expert service for clinical research sponsorship activities on behalf of the University of Oxford, including sponsorship review and authorisation, on-going oversight of compliance and providing support, guidance and training for academics, researchers, and research support professionals. You will work closely with researchers, research support staff and administrators across the University, including University departments and Clinical Trials Units, and with colleagues in the Joint Research Office, and external organisations (including the Health Research Authority (HRA), NHS RECs and the MHRA), to ensure that the University complies with applicable regulations and guidelines, whilst minimising the bureaucratic burden on researchers. **About You** To be successful in this wide-ranging and stimulating role, you will need to be someone who strives for excellence and enjoys providing high quality customer service. You will have extensive working knowledge of relevant legislation, GCP and HRA/NHS REC/MHRA policies and procedures. You will have great communication skills, and be confident in the ability to communicate to members of the public, students, and academic staff with courtesy and politeness. You will also have a positive attitude, be an exceptional line manager with an adaptable approach to your work, think innovatively when responding to changes in the clinical research governance landscape, and be comfortable when priorities suddenly need to change. RGEA works as an open, collaborative team, so an enthusiasm and ability to lead with others as a team player, to contribute to collective leadership, planning, and continuous improvement of the department overall, and actively championing our values and commitments will be essential. **Application Process** You will be required to upload a covering letter/supporting statement, CV and the details of two referees as part of your online application. If you would like to discuss this position, please contact Dr Ferdousi Chowdhury, (ferdousi.chowdhury@admin.ox.ac.uk). The closing date for applications is 12 noon on 29th July 2024. Interviews are anticipated to take place on week commencing 5th August 2024
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