Sites Quality Assurance Specialist
1 day ago
Job Opportunity: Sites Quality Assurance Expert
Our organization is seeking a highly skilled Sites Quality Assurance Expert to join our team. As a member of this role, you will be responsible for reviewing Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance.
The ideal candidate will possess excellent analytical skills, be able to effectively communicate with Clinical Project Managers (CPMs) and other project team members, and have a strong understanding of protocol requirements and IQVIA SOPs.
- Review SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines.
- Collaborate with CPMs at project start-up and throughout the study to provide guidance on SVR annotations.
- Provide coaching to Clinical Research Associates (CRAs) to decrease the level of corrections/additions needed on reports.
- Identify and track project team compliance to SOPs for submission and approval of SVRs through communication with CRAs and line managers.
- Participate on project teams for all SVR review activities and identifies and escalates CRA and/or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery.
Requirements:
- 4-6 years of relevant experience as a Clinical Research Associate.
- Minimum of 3 to 4 years of on-site monitoring experience.
- Basic therapeutic and protocol knowledge.
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