Clinical Research Associate II - Oncology

Responsibilities

• Conduct site monitoring visits (selection, initiation, monitoring, close-out) adhering to GCP and ICH guidelines.
• Collaborate with sites to develop and track subject recruitment plans to meet project needs.
• Provide protocol and study training to sites, maintaining regular communication to manage expectations and resolve issues.
• Assess site practices for quality and regulatory compliance, escalating issues as needed.
• Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data queries.
• Ensure site documentation is complete and maintained per GCP and regulatory standards.
• Document site management activities, visit findings, and action plans through reports and follow-up correspondence.
• Collaborate with study team members to support project execution.
• Potentially support site recruitment planning and financial management per agreements.

Requirements

• Bachelor's Degree in a scientific or healthcare discipline.
• 1.5–2 years of on-site CRA experience, preferably in oncology.

Skills

• Attention to regulatory detail
• Strong communication
• Organizational skills
• Ability to manage multiple study activities effectively