Quality Assurance Officer

University of Birmingham – Cancer Research (UK) Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences

Salary: Full time starting salary is normally in the range £32,348, with potential progression once in post to £42,155

Fixed Term contract up to December 2024

Background

The Cancer Research UK (CRUK) Clinical Trials Unit (CRCTU) is one of the largest UK Clinical Research Collaboration (UKCRC) registered clinical trials units in the country and specialises in running cancer clinical trials. The Unit has an extensive portfolio of phase I, II and III clinical trials in adults and children covering a wide range of disease sites. The Unit employs a multidisciplinary team of over 180 staff including statisticians, systematic reviewers, trial management staff, research nurses, trial monitors, programmers, administrators, and IT staff. The CRCTU receives substantial core funding from Cancer Research UK and additional funding from other charities, government, and pharmaceutical companies. 

Role Summary

The CRCTU is looking to appoint a Quality Assurance Officer.

The primary responsibility of the Quality Assurance Officers is to further develop and maintain the QMS; this involves writing SOPs and supporting documents, facilitating working groups across other CRCTU teams, and reviewing and updating existing documents. Some delivery of training to CRCTU staff is also involved.

They are also responsible for delivering audits both of internal processes and external collaborators or vendors in line with the CRCTU Internal and External Audit Programmes; this involves UK and potentially international travel, approximately four times per year. 

The Quality Assurance Officer will be a member of the Quality Management Team that is also responsible for delivery of on-site monitoring of the CRCTU trial portfolio, to ensure that trials are conducted, recorded, and reported in accordance with the protocol, GCP and the applicable legal regulatory requirements. The Quality Assurance Officer may take on on-site monitoring themselves throughout the UK and the Republic of Ireland and will support the Quality Assurance Manager with line management of Clinical Trials Monitors.

Person Specification

• A higher degree in a relevant biomedical or associated subject, or a graduate with high level of experience within clinical trials.
• Proven knowledge of the legal and regulatory framework which governs trial administration
• Shown experience in developing and/or maintaining quality management systems
• Ability to meet the travel needs of the post in the UK and internationally 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).

Hybrid working is possible in line with both CRCTU and University of Birmingham policies.

Informal enquires can be made to Sarah Bowden (email: s.j.bowden@bham.ac.uk).

To download the full job description and details of this position and submit an electronic application online please click on the Apply Online button below or visit our careers website; https://edzz.fa.em3.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_6001/requisitions quoting 46739.

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We value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible working

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