Clinical Operations Lead - Remote

Overview

The Clinical Operations Lead is responsible for overseeing the clinical operations of a project, ensuring compliance with study protocols and regulations while acting as a liaison between Clinical Research Associates (CRAs) and the clinical project team.

In Short

• Oversee project deliverables and CRAs.
• Conduct assessment visits and provide project-specific training.
• Implement enrollment and recruitment strategies.
• Prepare monitoring plans and documentation.
• Monitor site performance and compliance.
• Manage vendor activities as needed.
• Contribute to financial project management processes.
• Conduct regular CRA calls and status updates.
• Develop training materials and study tools.
• Ensure compliance with GCP and local regulations.

Requirements

• College diploma/degree with 7-9 years of experience or Bachelor's degree with 4-6 years of experience.
• Health Sciences, Life Sciences, or Nursing specialty preferred.
• Minimum of 3 years CRA experience.
• Strong experience with EDC systems and MS Office.
• Excellent written and verbal communication skills.
• Detail-oriented and highly organized.
• Ability to handle multiple tasks in a dynamic environment.
• Knowledge of clinical research documents and GCPs.

Benefits

• Home-based working conditions.
• Accommodations for persons with disabilities available upon request.