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Position: Sponsor Regulatory Advisor
Institution: University College London
Department: Clinical Research Support Centre
Location: London, United Kingdom
Duties: The Joint Research Office (JRO) has a central focus on providing research management and governance support to biomedical research studies across both Institutions and ensures researchers continue to contribute to the high scientific and cutting edge research that currently exists. The JRO provides research support services to facilitate compliance with regulations for an extensive portfolio of clinical research studies, involving IMP and Devices. The post holder will be responsible for oversight of the UCL portfolio assisting Investigator teams on behalf of UCL as sponsor to ensure the efficient coordination of clinical trials and that trials are set up and run in accordance with current regulatory requirements
Requirements: Applicants must be educated to degree level or equivalent and have a comprehensive understanding of the UK Clinical Trials Regulations, ICH Good Clinical Practice, The European Directives on Clinical Trials and Good Clinical Practice, the Department of Health's UK Policy Framework for Health and Social Care Research and with some relevant experience of ISO 14155, EU Regulation on Medical Devices 2017/745 and EU Regulation on In Vitro Diagnostic Medical Devices 2017/746
   
Text: Sponsor Regulatory Advisor, - Ref:1795073 Click here to go back to search results Apply Now UCL Department / Division Clinical Research Support Centre Specific unit / Sub department Joint Research Office Location of position London Grade 7 Hours Full Time Salary (inclusive of London allowance) ?35,328 - ?42,701 per annum Duties and Responsibilities The Joint Research Office (JRO) was established in August 2006. The JRO has a central focus on providing research management and governance support to biomedical research studies across both Institutions and ensures researchers continue to contribute to the high scientific and cutting edge research that currently exists. The JRO provides research support services to facilitate compliance with regulations for an extensive portfolio of clinical research studies, involving IMP and Devices. The post holder will be responsible for oversight of the UCL portfolio assisting Investigator teams on behalf of UCL as sponsor to ensure the efficient coordination of clinical trials and that trials are set up and run in accordance with current regulatory requirements. Key Requirements Applicants must be educated to degree level or equivalent and have a comprehensive understanding of the UK Clinical Trials Regulations, ICH Good Clinical Practice, The European Directives on Clinical Trials and Good Clinical Practice, the Department of Health's UK Policy Framework for Health and Social Care Research and with some relevant experience of ISO 14155, EU Regulation on Medical Devices 2017/745 and EU Regulation on In Vitro Diagnostic Medical Devices 2017/746. Excellent interpersonal skills to communicate effectively with researchers from different disciplines and at all levels of seniority and similarly administrators at all levels of seniority is also an essential requirement. Excellent interpersonal skills to communicate effectively with researchers from different disciplines and at all levels of seniority and similarly administrators at all levels of seniority is also an essential requirement. Further Details A job description and person specification can be accessed at the bottom of this page. To apply for the vacancy please click on the "Apply Now" button below. If you have any queries information regarding the vacancy please contact Farhat Gilani (Clinical Trials Operations Manager) f.gilani@ucl.ac.uk or 020 31086832 If you have any queries information regarding the application process please contact Alison Williams Alison.williams@nhs.net or 020 34475125 We particularly welcome applications from black and minority ethnic candidates as they are under-represented within UCL at this level. We will consider applications to work on a part-time, flexible and job share basis wherever possible. Closing Date 26 Mar 2019 Latest time for the submission of applications 23:59 Interview date TBC This appointment is subject to UCL Terms and Conditions of Service for Research and Support Staff. Please use these links to find out more about UCL working life including the benefits we offer and UCL Terms and Conditions related to this job. Apply Now
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