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4 days ago
The Site Report Specialist plays a critical role in ensuring the quality and integrity of site visit reports (SVRs). This involves reviewing SVRs to ensure they meet or exceed quality standards and support goals related to quality, subject safety, data integrity, and regulatory compliance.
">- Review SVRs for compliance with protocol, processes, timelines, IQVIA SOPs, and GCP guidelines.
- Provide guidance to clinical project managers at project start-up and throughout the study, partnering with the project team to minimize corrections and additions needed on reports.
- Offer coaching to CRAs to decrease the level of corrections/additions needed on reports.
- Identify and track project team compliance with SOPs for submission and approval of SVRs through communication with CRAs and line managers.
- Participate in project team activities for SVR review and identify/escalate CRA/site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner.
Required Skills and Qualifications:
- 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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