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5 days ago
This is a critical role in ensuring the quality and integrity of site visit reports.
Key Responsibilities:- Oversee a caseload of SVRs for assigned studies, ensuring compliance to protocol, processes, timelines, SOPs, and GCP guidelines.
- Provide guidance to Clinical Project Managers at project start-up and throughout the study, and partner with the project team members to decrease the level of corrections/additions needed on reports.
- Provide coaching to CRAs to decrease the level of corrections/additions needed on reports.
- Identify and track project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers.
- 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 quality of project delivery.
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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