Research Compliance Analyst IV

Job Summary

Providing advanced regulatory compliance oversight, the full-time Research Compliance Analyst IV will evaluate and monitor oncology clinical research activities, ensuring adherence to federal regulations and institutional policies while working remotely.

Key responsibilities

• Evaluate and monitor clinical research activities for compliance with regulatory documentation and investigational pharmacy practices
• Analyze and resolve complex compliance issues, ensuring participant safety and protocol adherence
• Serve as a senior technical resource and advisor on oncology clinical research compliance matters to leadership and research staff

Required qualifications

• Nine years of related experience or a Bachelor's degree in a related area plus five years of experience
• Advanced knowledge of federal, state, and university regulations governing human subjects research
• Experience supporting FDA submissions, including IND, IDE, and/or 510(K)
• Advanced experience with HHS, OHRP, FDA, HIPAA, GCP, and clinical research regulatory requirements
• Ability to execute core research compliance tasks, including reviewing protocols and conducting quality reviews