Duties and Responsibilities

The Clinical Trial Monitor will be a member of the JRO QA unit reporting directly to the Head of QA. The Clinical Trial Monitor will work alongside other members of the QA unit as and when required to ensure alignment with the overarching structure of the QA unit determined by the Head of Clinical Research Governance.

The Clinical Trial Monitor will be responsible for overseeing compliance of the CTIMP, portfolio sponsored by UCL. They will help ensure trials are conducted in compliance with Good Clinical Practice (GCP), UK regulations and research frameworks. 

The position will involve liaison with a wide range of academic, managerial and administrative staff across different UCL Faculties and Professional Service departments, and throughout UCLH. Interaction with the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA), National Research Ethics Service (NRES), Department of Health and Social Care (DHSC), as well as other academic institutions is essential to influence implementation of new requirements. A commitment to travel may be required for some multi centre trials.

There is a strong emphasis on team working to create systems for efficient support of the JRO and researchers alike. The role involves both central monitoring and on site monitoring of trial conduct and adherence to protocol, SOPs, regulatory requirements and GCP.

This role will support the development and maintenance of robust and effective QA processes within the infrastructure of an overarching quality management system (QMS) with a focus on continuous improvement in response to internal and external drivers. The post holder will work closely with other members of the JRO QA unit and governance teams.

Key Requirements

First degree in biomedical science or nursing. 

Training and/or experience in regulatory affairs relating to monitoring. 

MSc or equivalent degree in clinical research involving drug development and/or clinical research conduct. 

Comprehensive understanding of the role of monitoring trials to meet the UK Clinical Trials. Regulations, ICH Good Clinical Practice, the European Regulations on Clinical Trials, and the UK Policy Framework for Health and Social Care Research. 

Familiar with the regulatory processes in the UK required for authorising, conducting and terminating biomedical research. 

Experience of hands-on clinical research and/or regulatory affairs. 

Experience monitoring trials in a range of therapeutic fields to meet ICH Good Clinical Practice standards. 

Ability to evaluate risks inherent in clinical trials and decide those which should be prioritised to ensure that risks are properly managed and kept to a minimum with minimal support. 

Outstanding organisational skills, managing several projects that are often time pressured, concurrently. 

Ability to prioritise activities in spite of conflicting pressures.

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 regarding the vacancy please contact Helen Cadiou – Head of QA h.cadiou@ucl.ac.uk.

If you have any queries regarding the application process please contact Sham Islam – JRO Operations Manager shamimul.islam@nhs.net. 

The UCL Ways of Working for professional services supports colleagues to be successful and happy at UCL through sharing expectations around how we work – please see www.ucl.ac.uk/ways-of-working to find out more.

We particularly welcome applications from black and minority ethnic candidates as they are under-represented within UCL at this level.

Closing Date

5 NOV 2021

Latest time for the submission of applications

23:59

Interview date

TBC

Our department is working towards an Athena SWAN award. We are committed to advancing gender equality within our department.

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.