Senior Clinical Quality Specialist
Sarah Cannon Research Institute (SCRI) is the research arm of HCA Healthcare global cancer institute one of the world’s leading clinical research organisations conducting clinical trials throughout the United States and United Kingdom.
The organisation has led more than 220 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in more than two-thirds of approved cancer therapies over the last 10 years. Sarah Cannon Research Institute UK is a unique trial facility that collaborates and works closely with leading clinical investigators to develop new and innovative cancer therapies for patients. It is supported by a network of six hospitals and an outpatient unit supported by 70 oncologists.
The clinical trials are open to both independent sector and NHS patients, focused on fast study set-ups to offer rapid access to new investigational drug therapies.
As a Senior Clinical Quality Specialist, you will support the process improvement and internal/external audits within Sarah Cannon Research Institute UK, serving as the internal quality contact and resource for the department to support quality initiatives and projects.
Duties & Responsibilities
- Develop and maintain effective relationships with the investigative site and other SC departments and colleagues
- Mentor and work closely with the other Clinical Quality Specialists to ensure consistent support and effective outcomes for the investigative sites
- Prepare for and hosts external sponsor / IRB audits
- Work with Clinical Operations to obtain evidence of deliverables and facilitates effectiveness checks as needed to ensure CAPA closure.
- Review monitor letters for issue escalation and quality performance issues
- Develop a calendar for monitoring quality indicators/quality check (QC) and provides routine reporting of variances to the appropriate Clinical Quality Assurance (CQA) staff and operational leadership
- Identify areas of quality deficiency ensuring escalation to operational leadership and communication with appropriate CQA staff.
- Coordinate and facilitate quality review meetings with appropriate CQA staff and operational leadership
- Educates research staff in quality improvement methods
Skills & Experience
- Prior experience in Healthcare research or other science-related field
- Experience within quality assurance consulting and auditing experience in a GxP environment
- Knowledge of medical and clinical research terminology is highly desirable.
About The Individual