Clinical Research Monitor II

Responsibilities

• Independently conduct routine and for-cause monitoring of oncology clinical trials.
• Manage several priorities within multiple complex trials.
• Document monitoring observations, prepare written reports, and oversee issues through resolution.
• Apply seasoned judgment to identify compliance risks and trends; escalate concerns as appropriate.
• Work collaboratively with Principal Investigators and study teams to resolve findings and improve study conduct, including supporting the development of corrective and preventive actions (CAPAs).
• Contribute to the development, refinement, and maintenance of standard operating procedures (SOPs), tools, and templates.
• Participate in institutional research quality initiatives and process improvement efforts.
• Support onboarding, mentoring, and co-monitoring by modeling best practices and reinforcing quality expectations.

Qualifications

• Minimum of 7+ years of experience in clinical research monitoring (oncology experience preferred).
• In-depth knowledge of FDA regulations, GCP guidelines, and other relevant regulatory requirements governing clinical trials.
• Experience with electronic data capture (EDC) systems and electronic regulatory platforms.
• Effectively partners with cross-functional teams and external stakeholders to support study goals.
• Excellent organizational, analytical, and problem-solving abilities.
• Clinical research-related certification.
• Experience working in an NCI-designated cancer center or academic consortium environment.