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2 days ago
We are seeking a skilled Site Report Specialist to join our quality assurance team. In this role, you will be responsible for reviewing site visit reports to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance.
The ideal candidate will have experience in clinical research associate roles and a strong understanding of IQVIA SOPs, ICH/GCP guidelines, and protocol requirements.
Key Responsibilities:- Review site visit reports to ensure compliance with IQVIA SOPs, ICH/GCP guidelines, and protocol requirements.
- Provide guidance to Clinical Project Managers on project start-up and throughout the study.
- 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.
- 4-6 years relevant experience in clinical research associate roles.
- Minimum of 3 to 4 years on-site monitoring experience.
- Basic therapeutic and protocol knowledge.
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