Site Quality Assurance Specialist
4 days ago
We are seeking an experienced Associate Site Report Specialist to join our team. In this role, you will be responsible for reviewing site visit reports (SVRs) to ensure they meet or exceed quality standards and support the goals of quality, subject safety, data integrity, and regulatory compliance.
You will provide guidance to clinical project managers at project start-up and throughout the study, partnering with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of SVR annotations.
You will also identify and track project team compliance to SOPs for submission and approval of the SVRs through communication with CRAs and line managers.
Additionally, you will participate on the project team for all SVR review activities and identify and escalate CRA and/or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize the quality of project delivery.
- 4-6 years of relevant experience as a Clinical Research Associate.
- Minimum of 3 to 4 years of on-site monitoring experience.
This is an exciting opportunity for a detail-oriented and organized professional who is passionate about ensuring the highest quality of project delivery.
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