The Senior Clinical Research Associate I is responsible for overseeing clinical trial operations at the site level, ensuring adherence to protocols, regulatory standards, and project timelines. This role involves leading key monitoring activities, including site selection, initiation, routine visits, and close-out procedures, while maintaining accurate documentation throughout each phase.
Key Responsibilities
- Plan, execute, and report on all monitoring visit types, ensuring compliance with study requirements and regulatory expectations
- Conduct case report form reviews, verify source documents, and resolve data queries promptly
- Serve as the primary liaison between clinical sites and project teams, facilitating clear and consistent communication
- Lead country-level project team meetings to align on site progress, challenges, and recruitment goals
- Support subject enrollment by tracking recruitment metrics, identifying barriers, and implementing solutions
- Contribute to feasibility assessments and assist in site identification and selection
- Collaborate with regulatory specialists to prepare study-related documentation for submissions
- Prepare for and participate in audits and inspections, ensuring sites are inspection-ready at all times
Requirements
Candidates must demonstrate strong organizational skills, attention to detail, and experience managing clinical trial logistics. A background in therapeutic diversity and proven ability to coordinate with both sites and internal teams is essential. The role demands a proactive approach to problem-solving and a commitment to maintaining high-quality standards across all trial activities.
