Clinical Research Associate

Role Overview: Clinical Research Associate at Praxis Precision Medicines

At Praxis, we turn neuroscience discoveries into treatments that improve patients’ lives. As a Clinical Research Associate, you will play 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.

Key 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 Clinical Trial Managers (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

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus).
• 3+ years of clinical research experience, including site monitoring responsibilities.
• Strong knowledge of ICH-GCP, FDA regulations, and international trial standards.
• Excellent organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities and work independently as well as in a team.
• Willingness to travel as needed for monitoring visits (up to 50–75%).

Preferred Experience

• Previous experience in CNS or rare disease clinical trials.
• Strong understanding of GCP, FDA, and global trial regulations.
• Familiarity with registrational trial requirements.

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. We share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Key skills/competency

• Clinical Trial Monitoring
• ICH-GCP
• FDA Regulations
• Site Management
• Source Data Verification
• Clinical Research
• Protocol Compliance
• Trial Master File (TMF)
• Cross-functional Collaboration
• CNS/Rare Disease