Clinical Research Associate II

Job Summary

A company is looking for a Clinical Research Associate II (CRA II) for the East Coast SWAT, responsible for monitoring clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, and company SOPs.

Key Responsibilities:

• Contribute to the identification of new sites for clinical trials, analyze capability, and support in making recommendations for trial inclusion
• Implement complete site management including monitoring visits, regulatory assessment, and drug supply management to ensure compliance with protocol, GCP, global and local regulations
• Implement site close-out activities, generate site close-out reports, and provide feedback on site performance for future trial site feasibility/selection

Required Qualifications:

• Minimum 1-2 years prior monitoring experience with global trials
• In-depth knowledge of FDA regulations and ICH/GCP guidelines
• Ability to work effectively with investigators and other research personnel
• Ability to independently resolve site or study related issues
• CCRA or SoCRA certified