Clinical Research Associate (CRA)

Responsibilities

• Oversee and manage oncology clinical trial sites to ensure protocol compliance, data integrity, patient safety, and adherence to GCP, and SOPs.
• Conduct site qualification, initiation, interim monitoring, and close-out visits for oncology clinical trials.
• Ensure clinical trial activities are conducted in compliance with ICH-GCP, FDA regulations, and study protocols.
• Review and verify source data, case report forms (CRFs), and regulatory documentation for accuracy and completeness.
• Identify, document, and follow up on site issues, protocol deviations, and corrective action plans.
• Serve as the primary point of contact for investigative sites, providing ongoing training and support.
• Collaborate with cross-functional teams including Clinical Operations, Data Management, and Project Management.
• Prepare detailed monitoring visit reports and maintain accurate trial documentation.

Qualifications

• 3+ years of experience as a Clinical Research Associate monitoring interventional clinical trials.
• Hands-on experience performing onsite monitoring for oncology studies, ensuring GCP compliance and inspection readiness.
• Direct oncology trial monitoring experience is required.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical research best practices.
• Experience conducting remote and on-site monitoring visits independently.
• Excellent organizational, communication, and problem-solving skills.
• Ability to travel occasionally to investigative sites as required.

Pay

Salary range: $155,000 – $175,000 depending on experience

Schedule

Fully remote work environment with occasional travel