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Job Description 170384 - Research Support Manager
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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. Our research plays a key role in tackling many global challenges, from reducing our carbon emissions to developing vaccines during a pandemic. Research Governance Ethics & Assurance (RGEA) provides advice, support and guidance to researchers, and has a role in ensuring that clinical research involving human participants conducted by University members is compliant with relevant governance and regulations. This role involves reviewing applications and essential study documents for sponsorship approval prior to submission to NHS Research Ethics Committees and the Health Research Authority, as well as mentoring RGEA staff and new researchers in the requirements for clinical research. 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 You will join a group within RGEA whose primary role is to review clinical study proposals and amendments, to ensure they align with current legislation, policies and guidelines. This will involve communication with the study team as well as working with colleagues across RGEA and Research Services more widely. Our Research Support Managers fulfil reviewer activities as well as taking on signatory responsibility for studies and amendments. This may involve mentoring more junior colleagues and researchers. They may also contribute to more formal training and oversight provided by RGEA Research Support Managers provide advice to researchers and may be involved in the development, provision and maintenance of systems and standard operating procedures to ensure the University’s compliance with relevant regulations and standards of good practice. Internal and external training will be available, as required, to enable you to fulfil the role. About You You will have a University degree, or the equivalent relevant education and experience. You will have worked in a clinical research environment, ideally in an academic setting, and contributed to protocol development. Knowledge of legislation, policies and guidelines relevant to clinical research conducted in the UK is required for this role, and experience of delivering GCP training would also be beneficial. Strong communication and interpersonal skills are key for productive interactions with study teams and colleagues. You will also need to be able to work both independently as well as part of a team, and successfully organise your time and workload in a setting where there may be tight deadlines and the need to reassess priorities frequently. Application Process You will be required to upload a covering letter/supporting statement, CV and the details of two referees (including your current/most recent line manager) as part of your online application. Prospective applicants are welcome to contact Karen Melham (karen.melham@admin.ox.ac.uk) for an informal discussion about the position. The closing date for applications is 12 noon on 22 January Interviews will take place on 12 February and will be in person
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Job Description Job title Research Support Manager 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 8: £45,585 - £54,395 per annum with a discretionary range up to £59,421 Hours Full time or part time (80%FTE) Contract type Permanent Reporting to Sponsorship & Ethics Lead Vacancy reference 170384 Additional information The role You will join a group involved in the provision and maintenance of systems, SOPs and advice to ensure the University’s compliance with the relevant regulations. You may be involved in reviewing and advising on ethics applications and other essential documents, clinical trial planning, safety reporting, GCP monitoring, as well as providing relevant training and advice related to clinical research throughout the University. You will become a member of one of two groupings in the Research Governance Ethics & Assurance team (RGEA). In order to promote career progression, you will rotate between these groups, to enhance the breadth of your experience. Sponsorship & Ethics: This group specialises in the oversight of research sponsored by the University, with a wide range of research studies, ranging from interventional trials of new medical procedures; complex imaging studies; to student projects. These studies may be submitted to the Health Research Authority or one of the University research ethics committees. Regulatory & Quality Assurance This group focusses on the oversight of trials with regulatory compliance requirements: Clinical Trials of Investigational Medicinal Products (CTIMP) and regulatory device trials. Included within the group are Quality Assurance Managers, who will work closely with you. Responsibilities 1. Train and mentor RGEA staff in the conduct of high quality and professional work, whilst maintaining a risk-based and flexible approach to clinical research. Be a source of expert advice to junior team members, assisting in the resolution of complex difficulties arising through their work. Keep the team updated on national and international developments and updates to relevant legislation by presentations at team meetings, sending email alerts and organised team training sessions. Undertake line management of junior and administrative staff as required 2. Develop and maintain systems to ensure that studies are compliant with the appropriate requirements i.e.: UK Policy Framework for Health and Social Care 2017; The Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments; Guidelines for Good Clinical Practice (GCP); Human Tissue Act 2004; Mental Capacity Act 2005;The General Data Protection Regulation (GDPR); Declaration of Helsinki. 3. Through close collaboration with colleagues in the Joint Research Office (JRO), design, organise and deliver training modules on good clinical practice; good research practice; and obtaining ethical and HRA approvals appropriate to non-commercial studies and University policies. Design and provide specific training for departments as demand arises e.g. informed consent training, safety reporting. 4. Mentor and train new researchers on GCP, the regulations, ethics applications and other research related issues. Provide training to organisations outside the University as required. Facilitate communication between research teams to enable sharing of best practices with the objective of improving the general quality of research and compliance level within the University. 5. Develop, review and update Standard Operating Procedures and Document Templates for use within RGEA covering all aspects of clinical trials and research studies to facilitate compliance with the current regulatory requirements; considering the impact that such processes may have on the wider RGEA team and JRO colleagues. Work with the Operations & Training Lead to identify the need for new or updated content. Review RGEA web pages, ensuring that this remains current, clear and appropriate and enables convenient access to information relevant for compliance with the regulations. 6. Review clinical trials and research proposals on behalf of the University for sponsorship approval, both in the initial application and for subsequent amendments; undertaking risk assessment and quality check of the research protocol and the associated documents. Work with Risk & Insurance colleagues to ensure that the study is appropriately indemnified; and colleagues in the Funding & Contracts team, to ensure that appropriate agreements are put in place. Ensure that the information recorded in Studyline (the team’s portfolio management tool) is accurate and kept up to date. Investigate concerns arising with regard to compliance and conduct of clinical 2 research, through sensitive and confidential discussion with researchers and examination of study records. 7. Provide support and advice to researchers in connection with applications to the Medicines and Healthcare products Regulatory Agency (MHRA) for Clinical Trial Authorisations and on applications to the Health Research Authority and relevant Research Ethics Committees. 8. Assist researchers in planning new clinical trials to ensure that all aspects of the regulations have been considered and provide advice on development of protocol and associated documents and specific guidance on safety reporting requirements. Provide training and support during trial initiation e.g. conduct initiation visits and attend investigator meetings and set up of Trial Master Files. Arrange for the appropriate delegation of sponsor responsibilities to Chief Investigators 9. Train junior colleagues and undertake GCP monitoring of the University’s clinical trial and clinical research studies as required by the Regulations to ensure that research is compliant with the above regulations/guidelines. Lead on the conduct of compliance checks on a selection of Sponsored research studies 10. Conduct review of all Serious Adverse Events reported to the Joint University of Oxford/ OUH Trust Trials Safety Group. Ensure that all reportable Serious Adverse Events undergo appropriate review and enable prompt reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to the MHRA. Assist with putting in place safety reporting procedures in research teams in accordance with regulatory and Department of Health requirements 11. Prepare the relevant documents and files for inspection by the MHRA (or other regulatory bodies) of the University’s trials and facilities. Assist as required with the inspections by the MHRA (or other regulatory bodies). Provide advice and support to investigators of research studies selected for inspection, including University sponsored, third party sponsored or hosted studies. 12. Undertake other duties as required by the Director/Assistant Director RGEA or other senior officers of the University. Deputise for senior team members in their absence, as required. Selection criteria The person appointed must demonstrate that they have: Essential 1. A university degree (or the equivalent relevant education and experience) 2. Clinical research experience that includes protocol development 3. Proven track record of experience in clinical research, with a breadth of knowledge of the range of organisational and individual roles involved in contributing to sound research governance. 4. An interest in teaching, training and mentoring of adults in a clinical research environment. 5. Sound knowledge of UK Policy Framework for Health and Social Care 2017; The Medicines for Human Use (Clinical Trials) Regulations 2004 and its amendments; Guidelines for Good Clinical Practice (GCP); Human Tissue Act 2004; Mental Capacity Act 2005;The General Data Protection 3 Regulation (GDPR); Declaration of Helsinki; and the ability to interpret these in a non-commercial environment. 6. Experience of GCP monitoring or audit 7. Ability to work constructively as an individual and as part of a close-knit team 8. Flexible and adaptive approach to work with ability to prioritise and work effectively to tight deadlines 9. Excellent change management skills. Enthusiasm for implementing change and the ability to bring fresh thinking to research processes, enabling the team to develop and improve their systems 10. Excellent communication, persuasion, listening and strong interpersonal skills as well as attention to detail and a sharp analytical mind and an ability to think laterally 11. Excellent IT literacy: evidence of competence with MS Office, particularly Excel, Word, Powerpoint and Access Desirable 1. Experience of developing and delivering GCP training 2. Experience of working in an academic environment 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. 4 While we have long traditions of scholarship, we are also forward-looking, creative and cutting-edge. Oxford is one of Europe's most entrepreneurial universities and we rank first in the UK for university spinouts, 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/ 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 wide-ranging 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. 5 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). The world-leading medical and healthcare-related research conducted by OU and OUH 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. The JRO teams are shown in the organogram on page n and there is a brief introduction to each of them in this booklet. 6 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 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. 7 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 backup care for children, adult dependents and elderly relatives. See https://hr.admin.ox.ac.uk/my-familycare Childcare The University has excellent childcare services, including five University nurseries as well as Universitysupported 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. Our research plays a key role in tackling many global challenges, from reducing our carbon emissions to developing vaccines during a pandemic. Research Governance Ethics & Assurance (RGEA) provides advice, support and guidance to researchers, and has a role in ensuring that clinical research involving human participants conducted by University members is compliant with relevant governance and regulations. This role involves reviewing applications and essential study documents for sponsorship approval prior to submission to NHS Research Ethics Committees and the Health Research Authority, as well as mentoring RGEA staff and new researchers in the requirements for clinical research. **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** * You will join a group within RGEA whose primary role is to review clinical study proposals and amendments, to ensure they align with current legislation, policies and guidelines. This will involve communication with the study team as well as working with colleagues across RGEA and Research Services more widely. * Our Research Support Managers fulfil reviewer activities as well as taking on signatory responsibility for studies and amendments. This may involve mentoring more junior colleagues and researchers. They may also contribute to more formal training and oversight provided by RGEA * Research Support Managers provide advice to researchers and may be involved in the development, provision and maintenance of systems and standard operating procedures to ensure the University’s compliance with relevant regulations and standards of good practice. * Internal and external training will be available, as required, to enable you to fulfil the role. **About You** * You will have a University degree, or the equivalent relevant education and experience. * You will have worked in a clinical research environment, ideally in an academic setting, and contributed to protocol development. Knowledge of legislation, policies and guidelines relevant to clinical research conducted in the UK is required for this role, and experience of delivering GCP training would also be beneficial. * Strong communication and interpersonal skills are key for productive interactions with study teams and colleagues. You will also need to be able to work both independently as well as part of a team, and successfully organise your time and workload in a setting where there may be tight deadlines and the need to reassess priorities frequently. **Application Process** You will be required to upload a covering letter/supporting statement, CV and the details of two referees (including your current/most recent line manager) as part of your online application. Prospective applicants are welcome to contact Karen Melham (karen.melham@admin.ox.ac.uk) for an informal discussion about the position. The closing date for applications is 12 noon on 22 January Interviews will take place on 12 February and will be in person
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