Clinical Research Associate

Role Summary

At Praxis, we turn neuroscience discoveries into treatments that improve patients’ lives. The Clinical Research Associate (CRA) plays a key role in monitoring clinical trials and ensuring they are conducted to the highest quality and compliance standards. This position involves direct site management, monitoring visits, and close collaboration with site staff and cross-functional teams to support the successful execution of studies.

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.

Qualifications

• Required: Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus).
• 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.
• Preferred: Previous experience in CNS or rare disease clinical trials.
• Preferred: Strong understanding of GCP, FDA, and global trial regulations.
• Preferred: Familiarity with registrational trial requirements.

Additional Requirements

• Travel: Willingness to travel as needed for monitoring visits, up to 50–75% of the time.