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.