Regulatory and Governance Affairs Officer

Location: Leeds - main campus

Overview of the Role

We are looking for a Regulatory and Governance Affairs Officer to play a key role in the Quality Assurance department of a large nationally leading clinical trials unit. 

Do you have excellent knowledge of UK regulatory and governance requirements relating to clinical trials research? 

Do you have experience of audit and quality management in clinical trials?  

Do you want to be part of a leading team that has a national and international reputation for excellence in conducting complex, multi-centre clinical trials? 

The Leeds Institute of Clinical Trials Research is an international leader in the field of clinical trials. The Unit is one of the largest in the UK and conducts national and international randomised and early phase clinical trials in a variety of clinical fields. Our main aim is to support the challenge of changing clinical practice for the better and our past results and current work have already helped to do this. Our results inform the academic development of this specialised field of clinical research on a national and international level. Particularly, we specialise in complex phase III trials, efficient phase I/II trials, biomarker driven designs, seamless phase II/III designs, adaptive designs and the development and evaluation of complex interventions.  

You will join our Quality Assurance team to provide leadership and expert advice in relation to good clinical practice in clinical trials conduct. You will be responsible for managing the LICTR quality control and quality assurance systems which will include the review and update of standard processes; leading internal audits of clinical trials activity and reporting upon compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 (and subsequent amendments), UK Data Protection Regulation and Medical Devices Regulations 2002 (and any superseding legislation).  

What we offer in return

• 26 days holiday plus approx. 16 Bank Holidays/days that the University is closed by custom (including Christmas) – That’s 42 days a year!
• Generous pension scheme plus life assurance– the University contributes 14.5% of salary.
• Health and Wellbeing: Discounted staff membership options at The Edge, our state-of-the-art Campus gym, with a pool, sauna, climbing wall, cycle circuit, and sports halls.
• Personal Development: Access to courses run by our Organisational Development & Professional Learning team, and self-development courses including languages, Creative Writing, Wellbeing Therapies and much more.
• Access to on-site childcare, shopping discounts and travel schemes are also available.

And much more!

To explore the post further or for any queries you may have, please contact:

William Cragg, Regulatory and Governance Affairs Manager

Email: W.Cragg@leeds.ac.uk

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