Clinical Research – Human Subject Protection

Clinical Research – Human Subject Protection Overview

• The Clinical Research – Human Subject Protection role focuses on overseeing compliance and safety in clinical research operations.
• Lead the Human Subject Protection Program, ensuring adherence to regulatory standards and ethical guidelines.
• Collaborate with external IRBs and institutional committees to streamline research processes.
• Provide mentorship to a team of Research Program Analysts, fostering professional growth and development.
• Shape policies and educational frameworks to enhance research compliance and participant safety.
• Develop scalable processes and metrics to support continuous improvement in research operations.
• Act as a trusted advisor to investigators and organizational leadership on human subject protections.
• Contribute to enterprise governance and oversight through active participation in research councils.

Clinical Research – Human Subject Protection Key Responsibilities & Duties

• Lead operational and regulatory aspects of the Human Subject Protection Program.
• Serve as the primary liaison with external IRBs and biosafety committees.
• Oversee IRB reliance, local oversight, event reporting, and compliance monitoring.
• Mentor and manage a team of Research Program Analysts, ensuring effective team performance.
• Collaborate with Research Administration, Compliance, Legal, and clinical leaders.
• Shape policy, education, and risk-based oversight models for research compliance.
• Develop and implement scalable processes, metrics, and strategies for continuous improvement.
• Provide expert guidance to investigators and leadership on human subject protections.

Clinical Research – Human Subject Protection Job Requirements

• Bachelor's degree in Biological/Life Sciences or a related field.
• Minimum of 5 years of clinical research or research compliance experience within the United States.
• At least 2 years of leadership experience managing research-related personnel.
• Knowledge of external IRB processes and familiarity with regulatory standards such as 45 CFR 46 and HIPAA.
• Experience in monitoring, audits, investigations, and corrective action plans for research compliance.
• CIP or CHRC certification, or willingness to obtain within one year of hire.
• Proficiency with Microsoft Office and research compliance software.
• Preferred qualifications include a Master's degree, healthcare system experience, and familiarity with Epic research functionality.