Job Summary
A company is looking for a FSP CRA (Level I/II).
Key Responsibilities
- Monitor investigator sites using a risk-based approach and ensure compliance with protocols
- Conduct on-site and remote monitoring activities, including data accuracy assessments and documentation of observations
- Facilitate communication between investigative sites, clients, and internal teams while managing administrative tasks
Required Qualifications, Training, and Education
- Strong background in HSA and IRB submissions
- Knowledge of ICH-GCP regulations and compliance requirements
- Experience in conducting on-site file reviews and trial status tracking
- Ability to maintain accurate study systems and documentation
- Familiarity with project publications and process improvement initiatives
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