Clinical Research Associate

Job Summary

A company is looking for a Clinical Research Associate.

Key Responsibilities

• Monitor and oversee clinical trial sites to ensure compliance with protocols and regulatory requirements
• Manage relationships with CROs, vendors, and clinical trial sites, providing training and support as needed
• Ensure accurate reporting of adverse events and support inspection readiness activities

Required Qualifications

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred
• Minimum of 3+ years of clinical monitoring experience in biotech, pharma, or CRO environments
• Prior experience in monitoring cell therapy, gene therapy, or other complex therapeutic areas preferred
• Strong knowledge of ICH-GCP, FDA regulations, and global clinical trial requirements
• Experience with EDC systems, CTMS, eTMF, and safety reporting processes