Job Summary

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
• Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

Matching Summary

Skills & Requirements

Key Requirements

• Bachelor’s degree or RN
• Knowledge of GCP/ICH Guidelines
• Good computer skills
• Excellent communication skills
• Moderate critical thinking skills
• Ability to manage up to 75% travel

Work Rights