Clinical Trials Monitor

Job Purpose

The Monitor is responsible for on-site monitoring of CRCTU trials throughout the UK, the Republic of Ireland and other European countries, to ensure that a trial is run following the trial protocol and in accordance with current regulatory, ethical and quality standards. In addition to performing on-site monitoring, the Monitor supports the trial management team by advising on levels of monitoring, reviewing trial documents, assisting in the development of the trial’s quality management plan and providing advice on issues noted during in-house monitoring.
Furthermore, the Monitor contributes to the work of the wider Quality Management Team, including the writing of standard operating procedures (SOPs), performing training on relevant SOPs and encouraging the sharing of best practices across sites and within the CRCTU.

Person Specification

The applicant must have:
• A first degree in a relevant biomedical or associated subject.
• Experience in a clinical research environment in a research management and governance setting.
• Knowledge of the governance and legislative framework for conducting clinical trials, including Good Clinical Practice.
• Understanding of medical terminology.
• Project management experience.
• Effective communication (written and verbal), negotiation, presentation and interpersonal skills.
• Excellent organisational and time management skills.
• Ability to travel easily in the UK and further afield on occasion. Access to personal transport (i.e. car) and current (full) driving licence is required following training period for unaccompanied visits to sites. Overnight stays between visits may be required occasionally (3-4 times per year) and on occasion trips may include longer stays (up to 4 nights, Monday-Friday only).
• Ability to work on own initiative and problem solve. Capable of taking own decisions to organise the work of a professional team under management guidance.
• Demonstrate a critical and intelligent attention to detail and high standards of accuracy.
• Office management and clerical skills that include excellent word processing and document layout.