Senior In-House CRA

Job Summary

Supporting the management and monitoring of clinical studies, the full-time Senior In-House CRA will assist with operational activities, ensure compliance with protocols and regulatory requirements, and provide mentorship to junior staff while working remotely.

Key responsibilities

• Independently collects, reviews, and tracks essential documents for clinical trials, ensuring compliance with good documentation practices
• Communicates and coordinates effectively with internal project staff and site staff, providing trial progress updates and assisting in audit preparations
• Completes IRB/EC submissions and assists in training site staff while tracking recruitment efforts and resolving data discrepancies

Required qualifications

• Bachelor's Degree in a scientific discipline or directly applicable work experience
• 1-3 years of relevant clinical research experience (e.g., as a CTA, in-house CRA, or study coordinator)
• Proficiency in MS Office Suite and excellent organizational skills
• Knowledge of clinical research operations, including country-specific regulations and ICH guidelines
• Ability to work independently and collaboratively in a team-oriented environment