Clinical Research Associate New United States - Remote
Overview
At Praxis, we turn neuroscience discoveries into treatments that improve patients’ lives. The Clinical Research Associate (CRA) monitors clinical trials to ensure high quality and compliance. The role involves direct site management, monitoring visits, and collaboration with site staff and cross-functional teams to support study execution.
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 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 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.
Praxis Values
- Patients First
- Scientific Rigor
- Integrity
- Urgency with Purpose
- Accountability
The physical and mental requirements of our roles include regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You\'ll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Praxis offers a comprehensive total rewards package including competitive base salary, benefits coverage, and opportunities for performance-based incentives. Salary range for this role is $103,000 - $122,000 USD, and final figures may be modified commensurate with job level, education, and experience. Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders characterized by neuronal imbalance. Our core values are Trust, Ownership, Curiosity and Results. Equal Opportunity Praxis is an equal opportunity employer and is committed to providing opportunities to all qualified applicants without regard to race, religion, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. #J-18808-Ljbffr Salary: USD 103000 - 122000 per year Experience: 3 years required