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Barts Health is one of the largest NHS trusts in the country, and one of Britain’s leading healthcare providers.
The Barts Health group of NHS hospitals is entering an exciting new era on our improvement journey to becoming an outstanding organisation with a world-class clinical reputation. Having lifted ourselves out of special measures, we now have the impetus and breathing space to chart a fresh course in which we are continually striving to improve all our services for patients.
Our vision is to be a high-performing group of NHS hospitals, renowned for excellence and innovation, and providing safe and compassionate care to our patients in east London and beyond.
Barts Health supports the Pregnancy Loss Pledge and commits to supporting their staff through the distress of miscarriage.
Job overview
Applications are invited from individuals with a background in clinical research databases and a solid understanding of Good Clinical Practice (GCP). The successful candidate will join the Joint Research Management Office (JRMO), supported by systems/applications experts from Research IT Services (Queen Mary University of London) and the Research Data Warehouse Team (Barts Life Sciences Precision Medicine/Barts Health NHS Trust).
Main duties of the job
This newly established role within the JRMO involves leading the development, review, support, validation, training and oversight of clinical trials database management services for Queen Mary University of London and Barts Health NHS Trust.
The post holder will optimize the use of REDCap and other academic and commercial data management systems, ensuring these resources are compliant with regulatory requirements. They will be a key member of the GCP and Compliance Team, overseeing all aspects of database management for clinical research projects.
Qualifications and Experience
* A degree in a relevant subject.
* Prior experience with clinical trials databases.
* Comprehensive knowledge of governance and legislative frameworks for data capture in clinical research, including GCP.
* Technical skills in database creation.
* Strong communication skills to engage with a wide range of stakeholders.
Employment Details
* Full-time position.
* Based at the Joint Research Management Office, Barts Health, Dept. W, Mile End Road, with a current onsite attendance requirement of twice per week (subject to change).
Person specification
Qualifications
* Degree or equivalent level of professional qualification in subject area.
* Additional specialist knowledge/ accreditation gained through training and/or experience.
* Currently working on MHRA regulated studies.
Experience
* Proven experience of working with database systems in a research environment.
* Strong understanding of the current regulatory environment.
* MHRA inspection of clinical trial databases.
* Experience with REDCap application.
* Experience in writing complex SQL queries and presenting the results of those queries to non-technical users.
Knowledge
* Understanding of the key principles of legislation including Data Protect Act 2018 and the EU General Data Protection Regulation (GDPR).
* Knowledge of the MHRA Clinical Trial Regulations and its application to regulatory compliance of research databases.
Skills
* Proficient in database management with proven ability to apply skills to the development, testing and implementation of clinical trial data management procedures.
* Expert in identifying areas for collaborative work and analysing performance relating to clinical trial databases.
* Skilled in the design, maintenance of complex relational databases and clinical data management systems such as eCRFs.
* Excellent organisational, written, verbal communication and interpretation skills as well as a strong capacity to troubleshoot.
* Proven Administrative and project management skills.
Other
* Proficient in producing standard operating procedures and other guidance documents and oversee their implementation.
* Skilled in overseeing multiple active research projects, ensuring milestones are met and progress is communicated through high quality outputs.
* Excellent numeracy and accuracy skills with a high level of attention to detail.
Working for our organisation
Barts Health is committed to safeguarding the welfare of children and to child protection. The Trust aims to ensure as far as is possible that anyone, paid or unpaid, who seeks to work in our organisation and who gains access to children, is safe to do so. As such, you may be required to undertake a Disclosure and Barring Check as part of the recruitment process if appointed to a post with direct access to children or vulnerable adults.
As an Equal Opportunities Employer we actively support applications from individuals’ who apply under the Guaranteed Interview Scheme and will process your application as appropriate.
We reserve the right to expire vacancies prior to the advertised closing date once a sufficient number of applications has been received and we regret that we are unable to provide notification if your application is unsuccessful.
By applying for this post you are agreeing to Barts Heath NHS Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job, information will also be transferred into the national NHS Electronic Staff Records system.
You’ll have access to a range of benefits including one of the best pension schemes in the UK, leisure and entertainment discounts and parental leave and childcare support schemes we’re really proud of.
We're also committed to ensuring that you are supported in gaining and developing the skills and knowledge needed to carry out your work safely and effectively, and to achieve your full potential. We offer a range of apprenticeships at all levels, as well as an extensive range of career development opportunities.
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