We have an exciting opportunity for two Clinical Trials Administrative Coordinators to join the Experimental Medicine and Rheumatology group within Oxford Clinical Trials Research Unit (OCTRU) at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, to be based at the Botnar Research Centre. As a Clinical Trials Administrative Coordinator you will take responsibility for maintaining the Trial Master File. You will prepare documents such as trial specific instructions, investigator site file documents, progress trackers, newsletters, and short updates, using and adapting templates where available. You will deal with routine trial queries, passing non-routine queries to the Trial Manger or other senior staff where appropriate, and ensuring that any issues are resolved within a reasonable timeframe. You will carry out central monitoring to ensure trial is being run in line with the trial protocol and GCP requirements and will contact sites to resolve any issues. You must be educated to A-Level standard (or equivalent administrative qualifications/experience). You will have excellent IT literacy, including a strong working knowledge of Word, Outlook, and Excel. You will have proven administrative and data entry skills, experience of following and working to detailed written instructions, and the ability to maintain clear and accurate records. You should be self-motivated and able to respond well to changing priorities and deadlines, both independently and as part of a team. An understanding of data protection and other statutory requirements/ professional guidelines is essential, as is the ability to follow departmental guidance in handling sensitive and personal information. Previous experience of clinical research and data management are desirable. This is a full time fixed-term appointment for 36 months. (A part-time appointment at minimum 0.8 FTE over minimum 4 days would also be considered.) The closing date for this position is 12 noon on Monday 08 July. You will be required to upload a CV and supporting statement as part of your online application. Interviews are planned for the week of 22 July.
valid through (0..1)
email
Past vacancies at the University of Oxford
country name
es suborganización de
telephone
Fax
Job Description _________________________________________________________________________ Summary Job title Clinical Trials Administrative Coordinator Division Medical Sciences Division Department Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences Location Botnar Research Centre, Windmill Road, Oxford, OX3 7LD Grade and salary Grade 5: £28,759-£33,966 per annum Hours Full time (Part time considered, min 80% FTE over min 4 days) Contract type Fixed-term (36 months from 1st Sep 2024) Reporting to Clinical Trial Manager Vacancy reference 173595 The role The purpose of this role is to support the continued expansion of the Experimental Medicine and Rheumatology (EMR) trials portfolio following successful funding applications to the NIHR. As a Clinical Trials Administrative Coordinator, you will provide administrative support to the Trial Managers within the EMR group to facilitate the successful delivery of clinical trials to time and target. You will be responsible for the smooth coordination of activity such as site set up and data submission with minimal supervision. You will be responsible for planning and organising your own workload to meet the current priorities of the project. Successful clinical research involves collaboration with hospitals around the UK, and you will liaise with a variety of staff both within the trials unit and nationally. You will work as part of a multi-disciplinary team supporting studies through the various phases (set up, recruitment, data collection, monitoring, follow up, close out). The role will be mainly office based, but occasionally you may be required to travel within the UK such as to one of the participating sites. The post holder will also be expected to cover short periods of absence of the Trial Manager with support from senior staff. The post holder will have access to OCTRU’s extensive training programme delivered by a range of Trial Management professionals as well as other appropriate training opportunities offered by the University and externally, as well as being part of one of the largest and most diverse CTUs in the UK. Responsibilities 1. Prepare documents such as trial specific instructions, investigator site file documents, progress trackers, newsletters, and short updates, using and adapting templates where available. 2. Maintain the Trial Master File. 3. Support participating sites, including pharmacy staff, throughout the trial life cycle from set up to close out including the following activities to facilitate the site set up process: obtaining regulatory body and R&D approvals for sites, collating and checking required documents, and undertaking accreditation call; supporting the recruitment and follow up stage: ensuring sites have adequate trial supplies; ensuring timely and accurate data collection. 4. Deal with routine trial queries, passing non-routine queries to the Trial Manager or other senior staff where appropriate, and ensuring that any issues are resolved within a reasonable timeframe. Liaise with trial suppliers are necessary. 5. For any data collected on paper, enter data into trial databases, with a high level of accuracy. 6. Carry out checks on trial data for missing, inconsistent and incorrect information including liaising with sites about queries; undertake regular systematic check of data as required by the trial statistician, Trial Manager or trial documents. Ensure data queries are resolved within a reasonable timescale. 7. Assist with the testing of trial database systems. 8. Deal with Serious Adverse Events (SAE) that are reported, in line with SOPs and trial procedures. 9. Carry out central monitoring to ensure the trial is being run in line with the trial protocol and GCP requirements. Contact sites to resolve any issues identified. 10. Attend and contribute to regular team meetings. Provide short written and verbal updates/reports/metrics to senior staff when required. 11. Attend external meetings/visits such as site training and site monitoring visits – up to 4 per year. 173535 G5 CTAC JD FINAL.docx 2 12. Provide administrative support for meetings, with responsibility for organisation of meetings including bookings, preparation and distribution of agendas; taking, transcription and distribution of minutes; follow-up of action points arising from meetings. 13. Report issues or concerns to Trial Manager and/or senior staff. Use initiative to tackle any practical difficulties encountered under the guidance of the Trial Manager and/or senior staff. Be proactive in suggesting improvements to existing systems. 14. Be responsible for organising and planning own workload to meet research priorities, readjusting plans to respond as situations change or arise. 15. Provide cover for the Trial Manager as required and requested during any absences, alerting senior staff to any newly arising issues. 16. Undertake all activities in line with Standard Operating Procedures and in compliance with the Research Governance Framework for Health and Social Care, the Data Protection Act and other applicable legislation and guidance. 17. Undertake training as required by the post at the discretion of Trial Manager and/or senior staff. Selection criteria Essential selection criteria 1. Educated to at least A-Level standard or equivalent qualifications/experience. 2. Ability to demonstrate excellent IT literacy, including a strong working knowledge of Word, Outlook and Excel, with the ability to create and use spreadsheets. 3. Proven administrative and data entry skills. 4. Evidence of following and working to detailed written instructions and ability to maintain clear and accurate records. 5. Accuracy and attention to detail. 6. Excellent interpersonal and communication skills; confidence and proficiency in spoken and written English. 7. Self-motivated, with a flexible attitude and ability to respond well to changing priorities and to meet deadlines. 8. Ability to work independently and as part of a team. 9. Good organisational skills and the ability to manage own workload and prioritise based on management guidance. 10. Demonstrate an ability to follow departmental guidance in handling sensitive and personal information, including complying with current data protection legislation. 11. Demonstrate an understanding of data protection and other statutory requirements and professional guidelines, such as Good Clinical Practice guidelines. Desirable selection criteria 1. Previous experience of clinical research. 2. Previous experience of data management. 173535 G5 CTAC JD FINAL.docx 3 3. Experience of data entry into a database or data capture system. 4. Ability to travel in the UK. 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 173535 G5 CTAC JD FINAL.docx 4 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 cutting-edge. 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. Medical Sciences Division The Medical Sciences Division is an internationally recognised centre of excellence for biomedical and clinical research and teaching. We are the largest academic division in the University of Oxford. World-leading programmes, housed in state-of-the-art facilities, cover the full range of scientific endeavour from the molecule to the population. With our NHS partners we also foster the highest possible standards in patient care. For more information please visit: www.medsci.ox.ac.uk Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS) is part of the Medical Sciences Division and is the largest European academic department in its field, running a globally competitive programme of research and teaching. Our mission is to discover the causes of musculoskeletal and inflammatory conditions to deliver excellent and innovative care that improves people’s quality of life. Our highly skilled teams have expertise in a broad range of areas, including orthopaedic surgery, inflammation, immunology, rheumatology, medical statistics, epidemiology, and clinical trials. We currently have 480 staff, approximately 120 post-graduate students and have a grant portfolio worth over £180 million. 173535 G5 CTAC JD FINAL.docx 5 The Botnar Research Centre enables and encourages research and education into the causes of musculoskeletal disease and their treatment. The Centre provides world-class facilities for scientists in the field of musculoskeletal research. It takes a multidisciplinary approach, encompassing orthopaedic, rehabilitation and rheumatology clinical scientists, bone oncologists, laboratory scientists, epidemiologists, engineers and statisticians. The Botnar also hosts the Oxford Clinical Trials Research Unit (OCTRU) and the Centre of Statistics in Medicine (CSM), providing excellent statistical support to all aspects of clinical research. The Botnar opened in 2002, with a large annex completed in 2013. The Botnar is now home to around 300 staff and postgraduate students enjoying the international and friendly atmosphere of this workplace and benefits from the vast knowledge of leading experts in the field of musculoskeletal research. To accommodate its rapid growth, the Centre has opened another wing in early 2022. The new space provides additional 1000m2 of office and 1000m2 of laboratory space. The laboratory space includes a GMP clean room facility suitable for the manufacturing of biomaterials for human implantation. Sharing the site of the Nuffield Orthopaedic Centre, the largest specialist academic musculoskeletal hospital in the UK, puts the Botnar in a unique position to foster the collaboration between basic scientists and clinicians, which is essential to success in medical research. The Kennedy Institute is a biomedical research centre uniquely bringing together discovery science and earlystage clinical research, to develop transformative new therapies for chronic inflammatory and musculoskeletal conditions. Broadly focused on the thematic areas of immunity and microbiome, inflammation biology and tissue remodelling and repair, the Institute’s research is relevant for a range of common diseases such as arthritis, inflammatory bowel disease, fibrosis and cancer. The Institute has capacity for up to 260 staff and students who work collaboratively across 25 research groups. This enables a multidisciplinary approach of molecular and cellular biology, combined with analysis of disease models, patient tissue samples and longitudinal clinical data. Collectively, these studies seek to uncover the biological processes that maintain tissue health and how these pathways break down in disease. Research at the Institute is supported by a suite of core technology platforms, as well as through strategic partnerships with other basic and clinical research centres in Oxford, across the UK and internationally. These state-of-the-art technologies include the Oxford-Zeiss Centre for Excellence and other advanced microscopy and imaging facilities, mass and flow cytometry, as well as capabilities for microbial genomics and functional microbiome studies made available through the Oxford Centre for Microbiome Studies. Complementing a strong programme of lab-based research, the Institute has established a core of expertise and technologies in data science including single cell genomics, statistical genetics, computational biology, and research informatics. A recent extension to the Institute building with a new third floor creates additional space purposely designed for computationally intensive research. A true trendsetter in innovative and transformational research, the Kennedy also boasts a relaxed and friendly atmosphere, revolving around its bright and airy atrium that provides a space for colleagues to meet over coffee and tea to talk about their research and beyond throughout the day. For more information please visit: http://www.kennedy.ox.ac.uk 173535 G5 CTAC JD FINAL.docx 6 Athena Swan The Athena SWAN Awards specifically recognise success in developing employment practices to further and support the careers of women in science, technology, engineering, maths and medicine (STEMM) departments in academia. In May 2015 the charter was expanded to recognise work undertaken in arts, humanities, social sciences, business and law (AHSSBL), and in professional and support roles. Within NDORMS, we feel that we have an established culture of equality but are using the process to spur on-going improvement that benefits everyone involved in the Department. Our on-going progress was rewarded in May 2014 with an Athena Swan Bronze Award and in October 2015 with a Silver Award. Our development in this area has resulted in a number of commitments to our staff, central to which are: ➢ establishing an open, supportive and family-friendly research environment ➢ supporting career progression through teaching programmes, personal development reviews and mentoring ➢ proactive communication of support policies such as flexible working, provision of leave, promotion and career support schemes NDORMS aims to actively promote the implementation of the University’s family-friendly policies to help foster a family friendly working environment, including provision of family leave (such as policies for maternity, paternity, parental, carers and adoption leave), flexible/part-time working and scheduling inclusive meetings. The University’s childcare services support staff with a Childcare Voucher Scheme to help staff save tax and national insurance on childcare costs, offer information on nursery providers and a nursery fee Salary Sacrifice Scheme, work in partnership with playscheme providers to help support families during school holidays and signpost staff to parenting, local authority and other organisations that help support families and parents. The Department is also committed to ensuring that staff undertaking part-time or flexible working receive the same access to benefits and entitlements as full-time staff, including the same opportunities for training and promotion, a pro-rata entitlement to leave including bank holidays and careful consideration of requests to work part-time (particularly for those by staff returning from maternity leave). For more information please visit: http://www.admin.ox.ac.uk/personnel/staffinfo/benefits/family/ and http://www.admin.ox.ac.uk/personnel/during/flexible/ We are also actively working to uphold the University’s aim of providing an inclusive environment and equal career opportunities by promoting equality, valuing diversity and maintaining a working, learning and social environment in which the rights and dignity of all staff are respected. Separate University policies are also in place to ensure race, disability and gender equality. For more information, please visit: http://www.admin.ox.ac.uk/eop/ 173535 G5 CTAC JD FINAL.docx 7 Oxford Clinical Trials Research Unit (OCTRU) OCTRU is one of 52 UKCRC registered Clinical Trials Units, gaining full registration in 2012. OCTRU is a collaboration between three Clinical Departments within the University of Oxford: Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, Nuffield Department of Surgical Sciences and the Department of Oncology. OCTRU is one of the larger CTUs in the country. OCTRU aims to build on existing excellence in design, conduct and reporting in both early and later phase clinical trials in surgery, musculoskeletal sciences, experimental medicine, rheumatology and oncology. OCTRU is a flexible and responsive organisation that has been shown to be capable of identifying the most important questions for clinical trials, ensuring excellence in design, securing funding, and conducting trials within budget and on time. We expect our research to make a significant impact on patient care and to be world class in standard. For details of our current and past work please visit our website www.octru.ox.ac.uk Experimental Medicine and Rheumatology Trials Group (EMR) Led by Professor Duncan Richards, the EMR trials group is the newest group to work in collaboration with OCTRU. EMR manages a rapidly expanding portfolio of trials of varying sizes, spanning rheumatology and musculoskeletal conditions, experimental medicine, and COVID-19. The team is currently composed of Trial Managers, Trial Coordinators and administrative support staff under EMR’s Operational Lead, Dr Anne Francis. 173535 G5 CTAC JD FINAL.docx 8 How to apply Applications are made through our online recruitment portal. Information about how to apply is available 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 Application FAQs, including technical troubleshooting advice is available at: https://staff.web.ox.ac.uk/recruitment-support-faqs Non-technical questions about this job should be addressed to the recruiting department directly HR@ndorms.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 online recruitment portal to confirm receipt of your application. Please check your spam/junk mail if you do not receive this email. 173535 G5 CTAC JD FINAL.docx 9 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-privacypolicy. The University’s Policy on Data Protection is available at: https://compliance.admin.ox.ac.uk/dataprotection-policy. The University’s policy on retirement The University operates an Employer Justified Retirement Age (EJRA) for very senior research posts at grade RSIV/D35 and clinical equivalents E62 and E82, which with effect from 1 October 2023 will be 30 September before the 70th birthday. The justification for this is explained at: https://hr.admin.ox.ac.uk/the-ejra. For existing employees on these grades, 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 other grades 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. 173535 G5 CTAC JD FINAL.docx 10 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. 173535 G5 CTAC JD FINAL.docx 11
postal code
NTriples description of Clinical Trials Administrative Coordinator (Two posts)
Clinical Trials Administrative Coordinator (Two posts)
tiene sede principal en
a un site
alternative label
notation
Subject
Voice
Title
Turtle description of Clinical Trials Administrative Coordinator (Two posts)
Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)
Is Part Of
RDF/XML description of Clinical Trials Administrative Coordinator (Two posts)
locality
HTML description of Clinical Trials Administrative Coordinator (Two posts)
sede principale
tiene sede en
subOrganization of
Nuffield Orthopaedic Centre, Windmill Road
Source
Format
Address
street address
OxPoints
Notation3 description of Clinical Trials Administrative Coordinator (Two posts)
has exact match
Description of Clinical Trials Administrative Coordinator (Two posts)
has site
sous-Organization de
preferred label
ha sede
site principal
primary Site
sotto-Organization di
Unit price specification
extended address
NDORMS, Botnar Research Centre, Windmill Road, Oxford, OX3 7LD
License
address