Clinical Trials Monitor

We are seeking to appoint an experienced Clinical Trial Monitor to facilitate the set-up, monitoring and closing down of clinical trials in addition to delivering training to site staff as required. The role is based at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Headington, Oxford.

You will work alongside senior nursing staff to develop and write clinical trial monitoring plans based on the trial risk assessments and use your experience to suggest specific monitoring activities and schedules of monitoring visits. The role requires planning, co-ordination and monitoring of trial conduct at participating sites in accordance with the trial protocol, relevant SOPs, the trial specific monitoring plan, Good Clinical Practice (GCP) guidelines on clinical trial monitoring and applicable regulatory requirements.

You will be responsible for the monitoring of clinical trial progress at Oxford and external sites, using remote data/document review and/or on-site monitoring visits to identify and resolve issues. Effective tracking and documentation of all monitoring activities throughout the trial and any deviations from the monitoring plan. Working with senior nursing staff, you will review the monitoring plan on an ongoing basis, considering monitoring findings, any amendments to the protocol and changes to the trial risk assessment, and monitor recruitment and retention of trial participants. You will also monitor sample collection and accountability of study drug/medical devices/trial supplies a site level, and perform Source Data Verification (SDV) of study data. You will review participant informed consent forms, and (Serious) Adverse Events ((S)AE) to confirm timely and complete reporting and assess individual events for accuracy and completeness, in addition to any other trail monitoring tasks as required.

It is essential that you hold a degree in life sciences, nursing, biotech, medical sciences or other relevant subject and have experience in clinical trials, as well as proven and significant monitoring experience in multicentre randomised clinical trials in investigational medicinal products and/or medical devices. Experience of different monitoring activities including, remote, central and on-site monitoring is essential. A broad knowledge of clinical trial design and therapeutic areas, and comprehensive knowledge of relevant regulations and codes of practice, including clinical trial, medical device and data protection regulations, General Data Protection Regulation (GDPR), GCP, Good Clinical Laboratory Practice (GCLP) and Human Tissue Act (HTA) are essential to the role. Ability to work independently, effectively manage time, have excellent organisational skills, exceptional attention to detail, and excellent interpersonal skills, are also crucial to this role.

Applications for this vacancy are to be made online and you will be required to upload a supporting statement and CV as part of your online application. Your supporting statement must explain how you meet each of the selection criteria for the post using examples of your skills and experience.

This position is offered part time on a fixed term contract until 31 August 2026 and is funded by The Bill & Melinda Gates foundation and UKRI.

Only applications received before 12 midday on Wednesday 9 April 2025 will be considered. Please quote **177942 **on all correspondence.

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