The BCTU runs its trials in accordance with the current UK Clinical Trial Regulations, EU Clinical Trial Directives, NHS Research Governance Framework and tonational standards where appropriate. One of the key principles of GCP that is embedded in UK law is that systems should be implemented to assure every aspect of a trial. For this purpose BCTU has a Quality Management System (QMS), which contains Standard Operating Procedures (SOPs) and expands to training and performing internal audits. The one responsibility of the Quality Assurance Associate will be to further develop and maintain the QMS.
The Quality Assurance Associatewill be a member of the Quality Assurance Team that is also responsible for some monitoring activities of BCTU trials to ensure that a trial is conducted, recorded and reported in accordance with the protocol, Good Clinical Practice and the applicable legal regulatory requirements
- A higher degree in a relevant biomedical or associated subject, or a graduate with high level of experience within clinical trials.
- A good understanding of clinical research governance and the legislative framework for conducting clinical research studies, including Good Clinical Practice.
- Shown experience in developing and/or maintaining quality management systems A good understanding of trial management.
- Effective communication, negotiation, presentation, time management and interpersonal skills. Ability to meet the travel needs of the post in the UK and further afield on occasion.
- Overnight stays between visits are required sporadically (2-3 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.