Clinical Research Associate II

The Clinical Research Associate II (FSP) role involves overseeing site management to ensure patient safety and data integrity. This position is essential for guiding audit readiness, maintaining trial tools, and managing regulatory submissions while performing both on-site and remote monitoring activities.

Key Responsibilities

• Oversee site management to protect patient safety and data quality.
• Guide audit readiness and follow-up actions.
• Maintain trial tools, tracking systems, and status reports.
• Manage site start-up tasks and regulatory submissions.
• Perform on-site and remote monitoring per protocol.
• Document activities and support recruitment and retention efforts.

Required Skills & Qualifications

• Bachelor's degree in a scientific or healthcare field.
• 2+ years of experience as a CRA in CRO/pharma or biotech.
• Excellent communication and organizational skills.
• Experience monitoring oncology trials.
• Proficient with electronic systems, spreadsheets, and email.
• Ability to travel up to 60% and internationally.