
Senior Site Monitor
Há 5 dias
The role of a Clinical Research Associate II is to assume primary responsibility for conducting site visits and serving as the site manager.
This involves building and maintaining relationships with key site personnel, ensuring effective communication and monitoring data quality and patient safety through monitoring and site education.
The Clinical Research Associate II is responsible for completing all aspects of the clinical monitoring process in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs.
Key Responsibilities:- Perform and coordinate assigned aspects of the clinical monitoring process
- Conduct site visits to determine protocol and regulatory compliance
- Develop collaborative relationships with investigative sites and study vendors
- Provide protocol and related study training to assigned clinical study sites
- Maintain oversight of site performance by tracking metrics for enrollment, data entry into Case Report Forms (CRFs), protocol deviation trends, and overall site issues
This position also serves as mentor/trainer for less experienced CRAs, assists with general and study-specific monitoring issues, and communicates site performance to the Clinical Study Team (CST).
The ideal candidate will have a BS/BA in a relevant scientific discipline and minimum 2+ years of relevant Clinical Operations experience, and minimum 1+ year of monitoring experience. Experience in global oncology trials is preferred.
Requirements:
- BS/BA in a relevant scientific discipline
- Minimum 2+ years of Clinical Operations experience
- Minimum 1+ year of monitoring experience
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