Clinical Research Associate - Early Development
Company: Fairview Hospital / Cleveland Clinic
- Location: Boston, United States
- Employment type: Full-time
- Posted: 9 days ago
- Offer language: English
Job description
Role Overview
We are seeking a dedicated Clinical Research Associate (CRA) to monitor and manage Phase I clinical trials, ensuring compliance with study protocols, regulatory standards, and sponsor expectations.
Key Responsibilities
- Conduct site visits—selection, initiation, monitoring, and close-out—aligned with GCP and ICH guidelines.
- Collaborate with site staff to implement recruitment strategies and track enrollment goals.
- Provide protocol and study-specific training to site personnel, maintaining clear communication.
- Assess site performance, address quality concerns, and ensure data integrity.
- Monitor study progress through regulatory submissions, subject enrollment, and data queries.
- Ensure proper documentation of activities in TMF and ISF per regulatory standards.
- Document activities, visit outcomes, and follow-up actions thoroughly.
- Support study execution by working with cross-functional teams, including recruitment planning and financial management.
Qualifications & Skills:
- Bachelor’s degree in life sciences or related field, or equivalent experience.
- At least 1.5 years of on-site monitoring experience.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
- Willingness to travel as needed.
