Full Job Description
This position supports regulatory compliance for complex clinical research studies and ensures adherence to federal, state, sponsor, and institutional requirements. The role manages regulatory submissions, maintains high-quality documentation, and collaborates with study monitors to ensure timely, compliant study activation and ongoing study oversight.
Key Responsibilities:
• Review clinical research protocols and prepare, manage, and submit all regulatory documents required by UCLA, FDA, NCI, IRB, and study sponsors.
• Maintain complete and accurate regulatory files; ensure timely collection of essential study documents.
• Work with study monitors to address queries and ensure compliance with all applicable laws, regulations, and policies.
• Audit and monitor interventional clinical trials overseen by the JCCC Data and Safety Monitoring Board (DSMB).
• Review external monitoring/audit reports for institutional oncology trials and track required follow-up actions.
• Maintain and update the JCCC Clinical Trial Database to meet UCLA, FDA, and NCI reporting requirements.
• Interpret regulations and determine applicability to JCCC studies; communicate compliance expectations to study teams.
• Review and approve patient eligibility for DSMB-monitored studies according to established guidelines.
Salary: $6,868.75 - $14,315 monthly
