Clinical Quality Specialist
Apply NowLocation:
Nashville, TN, US
Company:
Sarah Cannon Research Institute (SCRI) focuses on advancing oncology treatments and improving outcomes for cancer patients through community-based research.
Summary:
The Clinical Quality Specialist supports process improvement and audits within the Investigative Site to enhance quality initiatives. An Associate’s Degree and relevant experience in clinical research are required.
Requirements:
Hard Skills: Quality Assurance
Credentials: Associate’s Degree, Bachelor’s Degree
Experience: Minimum 1+ year experience in clinical research, pharmaceutical, biotech, or healthcare
Job Description:
Our Clinical Quality Specialist supports process improvement, and internal/external audits within the Investigative Site serving as the internal quality contact and resource for the department to support quality initiatives and projects.
Duties include and are not limited to:
- Prepares for and hosts external sponsor / IRB audits
- Assists sites with Root Cause Analysis and responses to external audits and CAPAs
- Facilitate effectiveness checks to ensure CAPA closure
- Reviews monitor letters for issue escalation and quality performance issues
- Monitors quality indicators/quality check (QC) using risk-based approach within framework of Quality by Design (QbD).
- Identifies areas of quality deficiency ensuring escalation to operational leadership and communication with appropriate CQA staff.
- Coordinates and facilitates quality review meetings with appropriate CQA staff and operational leadership
- Communicates with monitors and auditors as needed
- Assists research staff in maintaining regulatory compliance and QA standards
- All other duties as assigned
Qualifications needed
- Associate’s Degree required, Bachelor’s Degree preferred - Work experience may be substituted for education
- Minimum 1+ year experience in a clinical research, pharmaceutical, biotech, or healthcare utilizing medical and clinical research terminology
- Experience with Electronic Medical Record (EMR) highly preferred
- Experience working in a fast-paced environment with a multi-team organization
- Quality Assurance experience highly preferred
