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WTC Clinical Vaccinology and Tropical Medicine
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Department of Paediatrics, Oxford Vaccine Group, Churchill Hospital, Oxford
_________________________________________________________________________ Job description and selection criteria Job title Clinical Trials Assistant (with play) Division Medical Sciences Department Paediatrics Location Oxford Vaccine Group, CCVTM, Churchill Hospital, Oxford Grade and salary Grade 4: £25,138 to £28,759 per annum (with a discretionary range to £31,396 per annum) Hours Full time (36.5 hours per week) Contract type Fixed-Term for 12 months in the first instance Reporting to Jack Howes, Clinical Trials Coordinator Vacancy reference 170577 The role Overview of the role Under minimal supervision the Clinical Trials Assistant is responsible for the effective and efficient day to day administration of research studies to enable the academic research staff to fulfil their responsibilities. The Clinical Trials Assistant is also required to carry out varied office duties and specific study related tasks and acts as a pivotal point of contact for the clinical trial team. The role includes assisting the paediatric study team by providing distraction to babies and children on visits within the community. Responsibilities • To administer, maintain and coordinate the logistical aspects of the clinical trials according to Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs). • To liaise with study participants and/or the study team to book appointments, resolve disrupted appointment times, offer new appointments and re-arrange existing appointments according to protocol timelines. • To monitor and maintain the study documents, databases, spreadsheets and equipment. • To establish and be able to maintain effective filing systems including case report forms, investigator site files and administrative files. • To liaise with the external printing company in preparing and ordering the printing of study documents. • To ensure an initial supply of documents, paperwork and other equipment is ready for the start of the trial. • To send weekly recruitment updates to those involved in the studies. • To attend study meetings, including developing the agenda as well as recording the minutes and action points. • Be responsible for creating and maintaining study databases to track the recruitment and progress of clinical studies. • To be responsible for ordering and tracking participant payments for studies. • To proof-read documents thoroughly before regulatory submissions and print runs. • To monitor University Sponsored Studies within the group according to Good Clinical Practice Guidelines and study specific protocols, highlighting errors and discrepancies and bring these to the attention of senior study staff. • Be responsible for organisation/management of the Group’s research archive files, including maintaining a database of archived materials and summaries of current/previous research activities. • Maintenance of staff training records and provide support in training new starters. • To maintain confidentiality of issues relating to the families participating in research studies. • To adhere to Oxford Vaccine Group Standard Operating Procedures for the conduct of studies. • To be aware of the DoH Research Governance Framework for Health and Social Care governing the conduct of research. • Communicate effectively with colleagues, as well at study participants, using initiative and judgment to solve problems and provide feedback to senior colleagues as appropriate. • To undertake clinic support duties such as; being the receptionist on clinic to welcome participants, frequently collect samples taken in clinic and deliver them to the local lab team, sign in/out participants, observation of participants post vaccination and appropriate tasks to facilitate the successful running of the clinic. • General office administration in this role as appropriate: • Photocopying, shredding, filing and arranging couriers • To assist the study team with any other data collation and general office duties • Deal with queries from members of the public, study participants, employees and line managers over the phone, by fax, by email and face-to-face Other duties, to be defined from time-to-time, where appropriate to the grade • Department of Paediatrics, OVG Clinical Trials Assistant, Job Description 2 Paediatric Studies • • • To assist the study team when obtaining venous blood samples from babies and children by holding and providing distraction to the participant and family To assist the clinical team when vaccinations are given or samples taken To attend in service training, including child protection training and be aware of current trends in childcare Selection criteria Essential 1. Experience in research clinical trials administration including working knowledge of regulatory and governance requirements for clinical trials 2. Demonstrable experience in an administrative role working in an office environment 3. Excellent written and oral communication skills 4. Proven evidence of excellent organisational and time management skills 5. Ability to work unsupervised taking responsibility for own actions, including appropriate use of initiative and problem solving 6. Comprehensive knowledge of standard office software packages and IT skills including database entries and queries (Excel and Access) 7. Experience working with confidential information for example medical records or clinical trial participant information 8. Service oriented approach, flexible, reliable and proactive towards changing study teams needs 9. Ability to work precisely according to procedures, rules and regulations 10. Experience and/or knowledge of monitoring clinical research trials 11. Ability to be flexible in working hours according to study requirements 12. Experience of working with babies/children 13. Willingness to assist the research team with venepuncture and vaccination in babies and children 14. Willingness to attend a resuscitation course 15. Current driving licence with use of own car (or ability to travel independently across the Thames Valley for clinical trial visits) Desirable 1. 2. 3. 4. Experience of university procedures and computer systems Further education qualification in administrative field Experience with proof reading documents and document creation A formal childcare qualification Department of Paediatrics, OVG Clinical Trials Assistant, Job Description 3 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. . If you have previously worked for the University we will also verify key information such as your dates of employment and reason for leaving your previous role with the department/unit where you worked. 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 Hazard-specific / Safety-critical duties This job includes hazards or safety-critical activities. If you are offered the post, you will be asked to complete a health questionnaire which will be assessed by our Occupational Health Service, and the offer of employment will be subject a successful outcome of this assessment. The hazards or safety-critical duties involved are as follows: • Working with blood, human products and human tissues • Work in clinical areas with direct contact with patients Additional security pre-employment checks This job includes duties that will require additional security pre-employment checks. • A satisfactory enhanced Disclosure and Barring Service check due to regulated activity involving children. • University security screening (e.g. identity checks) Department of Paediatrics, OVG Clinical Trials Assistant, Job Description 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 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. Oxford Vaccine Group The Oxford Vaccine Group staff are based within a purpose built centre on the Churchill Hospital site and is part of the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM). Administration of the Oxford Vaccine Group is provided by the University Department of Paediatrics which is currently situated in the Children’s Hospital at the John Radcliffe site. The Department has clinical and research facilities both within the main hospital, the Women's Centre and the Weatherall Institute of Molecular Medicine, and has a major interest in infectious diseases of infancy and childhood. The aim of the Oxford Vaccine Group (OVG) is to co-ordinate expertise in the study of infectious disease and immunology in order to facilitate research on the development and implementation of vaccines. This may include new, improved or combined vaccines. The Oxford Vaccine Group is led by Professor Andrew J Pollard, Professor of Paediatric Infection and Immunity. Core group members include a Clinical Team Leader, Consultant Vaccinologist, clinical research fellows, research nurses, research assistants, play assistants and secretarial support. Wider group members include professionals from a range of specialities including adult infectious diseases, tropical medicine, immunologists, microbiologists, a statistician, a community paediatrician, a public health consultant and the district immunisation co-ordinator. Recent studies of the group include: Department of Paediatrics, OVG Clinical Trials Assistant, Job Description 5 • • • • • • New generation meningococcal conjugate vaccines Meningococcal B vaccine development Pneumococcal conjugate vaccine studies An H1N1 vaccine study Development of a typhoid challenge model An Ebola vaccine Phase 1 trial For more information please visit: www.paediatrics.ox.ac.uk/ovg Department of Paediatrics The Department of Paediatrics is a world leader in child health research and hosts internationally renowned research programmes in drug development, gastroenterology, haematology, HIV, immunology, neuroimaging, neuromuscular diseases and vaccinology. Our work spans from early proof-of concept fundamental science, all the way up to its application in clinical settings. We continue to shape the landscape of medical science through positively impacting the lives of millions of children from our global research programmes, academic resources, and commitment to success. Our broad research base positions the department in a pivotal role and subsequently a world leader in child health. With research facilitates in the UK and abroad, we work on a global scale, building a paediatric network in the medical science community. We are committed to inform and inspire external audiences worldwide through our public engagement and outreach activities. In 2021, we successfully administered a grant value of £130,895,28 obtained through 168 projects. Our strong relationship with funding bodies have also been a contributor to the successes and milestones in children’s health research. With strong support from the Wellcome Trust, NIH, Cancer Research UK, UKRI, MDUK, Bill & Melinda Gates Foundation, Academy of Medical Sciences and the NIHR, we have employed 360+ staff, researchers, and students. These figures continue to grow as we expand our activities to overcome the multitude of challenges within children’s research health. For more information please visit: http://www.paediatrics.ox.ac.uk/ The Department of Paediatrics holds a silver Athena Swan award to recognise advancement of gender equality: representation, progression and success for all. Medical Sciences Division We are an internationally recognized centre of excellence for biomedical and clinical research and teaching, and 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: http://www.medsci.ox.ac.uk/ Department of Paediatrics, OVG Clinical Trials Assistant, Job Description 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 and recruitment@paediatrics.ox.ac.uk if the application form used for the vacancy does not allow attachments). If you need help Application FAQs, including technical troubleshooting https://staff.web.ox.ac.uk/recruitment-support-faqs advice is available at: Non-technical questions about this job should be addressed to the recruiting department directly at recruitment@paediatrics.ox.ac.uk or using the contact details in the online advertisement. 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. 7 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. 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 of 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. 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 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. Oxford Research Staff Society (OxRSS) A society run by and for Oxford University research staff. It offers researchers a range of social and professional networking opportunities. Membership is free, and all researchers employed by Oxford University are welcome to join. Subscribe at researchstaff-subscribe@maillist.ox.ac.uk to join the mailing list to find out about upcoming events and other information for researchers, or contact the committee on committee@oxrss.ox.ac.uk. For more information, see www.ox.ac.uk/oxrss, Twitter/ X @ResStaffOxford, and Facebook www.facebook.com/oxrss. 9
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NTriples description of Clinical Trials Assistant (with play)
Join the team that has recently gained large recognition due to the unprecedented speed of activity in the race against the global threat to human health that is coronavirus. With over 25 years of experience in vaccine research, the Oxford Vaccine Group undertakes vaccine research at all stages of the process from pre-clinical development to late phase policy influencing trials, with the sole aim of ensuring protection of as many individuals as possible from vaccine preventable diseases. We are looking to recruit a **Clinical Trials (including Play) Assistant**. Under minimal supervision, the postholder is responsible for the effective and efficient day-to-day administration of specific research studies to enable the academic research staff to fulfil their responsibilities. The postholder is required to carry out varied office duties and specific study related tasks, including assisting the paediatric study team by providing distraction to babies and children on visits within the community. This is a varied role in a friendly and hard-working team and we are looking for someone with effective communication and inter-personal skills, experience of working with babies/children, excellent office management and organisational skills with the ability to prioritise own workload effectively. Due to the nature of the role this is on site working at the Churchill Hospital, Headington. You will be required to upload a CV and Supporting Statement as part of your online application. The Supporting Statement should include a cover letter and should also clearly describe how you meet each of the selection criteria listed in the job description. Click here for information and advice on writing an effective Supporting Statement. To discuss the post in more detail, please contact Emma Plested using the contact details below. Only online applications received before 12.00 midday on 05/03/2024 will be considered. Interviews will be held as soon as possible thereafter.
Standard Grade 4: 25,138 - 28,759 (with a discretionary range to £31,396) per annum
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Join the team that has recently gained large recognition due to the unprecedented speed of activity in the race against the global threat to human health that is coronavirus. With over 25 years of experience in vaccine research, the Oxford Vaccine Group undertakes vaccine research at all stages of the process from pre-clinical development to late phase policy influencing trials, with the sole aim of ensuring protection of as many individuals as possible from vaccine preventable diseases. We are looking to recruit a Clinical Trials (including Play) Assistant. Under minimal supervision, the postholder is responsible for the effective and efficient day-to-day administration of specific research studies to enable the academic research staff to fulfil their responsibilities. The postholder is required to carry out varied office duties and specific study related tasks, including assisting the paediatric study team by providing distraction to babies and children on visits within the community. This is a varied role in a friendly and hard-working team and we are looking for someone with effective communication and inter-personal skills, experience of working with babies/children, excellent office management and organisational skills with the ability to prioritise own workload effectively. Due to the nature of the role this is on site working at the Churchill Hospital, Headington. You will be required to upload a CV and Supporting Statement as part of your online application. The Supporting Statement should include a cover letter and should also clearly describe how you meet each of the selection criteria listed in the job description. Click here for information and advice on writing an effective Supporting Statement. To discuss the post in more detail, please contact Emma Plested using the contact details below. Only online applications received before 12.00 midday on 05/03/2024 will be considered. Interviews will be held as soon as possible thereafter.
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