Clinical Research Associate II

Job Summary

Supporting clinical trials remotely, the full-time Clinical Research Associate II will manage site-related tasks, assist with documentation, and collaborate with project teams to ensure compliance with regulatory standards in CNS and Oncology studies.

Key responsibilities

• Coordinate study materials and assist with site documentation for the Trial Master File (TMF)
• Conduct remote monitoring visits and support field Clinical Research Associates (CRAs) with Investigator Site File (ISF) maintenance
• Provide mentorship and training for In-house CRA I and II team members

Required qualifications

• Bachelor's degree in medical, biological, physical, health, pharmacy, or related science
• Minimum of two years of clinical research experience, specifically in Oncology and CNS/Neurology
• Good understanding of FDA and EU regulations, ICH Guidelines, and clinical research principles
• Familiarity with electronic data capture systems (EDC) and standard operating procedures
• Basic knowledge of Microsoft Office applications