Clinical Research Associate

Role Summary

The Clinical Research Associate (CRA) monitors clinical trials to ensure they are conducted to the highest quality and regulatory compliance. This role involves direct site management, monitoring visits, and close collaboration with site staff and cross-functional teams to support successful study execution.

Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, ICH-GCP, and regulatory requirements.
• Verify source data and ensure accuracy, completeness, and consistency with case report forms (CRFs) and study databases.
• Review monitoring reports and follow-up letters to ensure timely resolution of issues.
• Assist CTMs in site activation activities and provide ongoing site management support.
• Collaborate with cross-functional teams (Data Management, Medical, Regulatory, Quality) to maintain high-quality trial conduct.
• Identify and escalate protocol deviations, data integrity issues, and safety concerns.
• Maintain study files and documentation, ensuring compliance with SOPs and trial master file (TMF) requirements.
• Support investigators and site staff with training and guidance on study procedures.

Education

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field

Qualifications

• Required: 3+ years of clinical research experience, including site monitoring responsibilities.
• Required: Strong knowledge of ICH-GCP, FDA regulations, and international trial standards.
• Required: Excellent organizational, communication, and problem-solving skills.
• Required: Ability to manage multiple priorities and work independently as well as in a team.
• Required: Willingness to travel as needed for monitoring visits (up to 50–75%).
• Preferred: Advanced degree in related field.
• Preferred: Previous experience in CNS or rare disease clinical trials.
• Preferred: Strong understanding of GCP, FDA, and global trial regulations; familiarity with registrational trial requirements.