Clinical Research Associate
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Job Description
Clinical Research Associate monitoring clinical trials for drug development at Praxis Precision Medicines. Ensuring compliance and conducting site management to improve patients' lives.
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.
Requirements:
- 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%).
Benefits:
- 99% of the premium paid for medical, dental, and vision plans.
- Company-paid life insurance.
- AD&D and disability benefits.
- Voluntary plans to personalize coverage.
- Dollar-for-dollar 401(k) match up to 6%.
- Long-term stock incentives and ESPP.
- Discretionary quarterly bonus.
- Extremely flexible wellness benefit.
- Generous PTO.
- Paid holidays and company-wide shutdowns.
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