Jobs · Analyst · Massachusetts

Clinical Research Associate - Early Development

Fairview Hospital / Cleveland Clinic · Boston, MA · 1 wk ago
On-siteAnalystFull-time
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.

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