Human Research Quality Manager

Job Summary

A company is looking for a Human Research Quality Manager to oversee quality assurance monitoring and auditing of human research studies.

Key Responsibilities

• Conduct quality assurance monitoring and auditing of human research studies to ensure compliance with regulations and IRB protocols
• Provide regulatory assistance to clinical researchers throughout the study lifecycle
• Collaborate on educational priorities and quality improvement initiatives within the Human Research Protection Program

Required Qualifications

• Bachelor's degree required; Master's degree preferred
• At least 4 years of experience in human subjects research (e.g., IRB staff, study coordinator, monitor/auditor)
• Experience with clinical research, including pharmaceutical/device trials or public health research
• Knowledge of REDCap functionalities and HIPAA regulations for research
• Expert understanding of policies and regulations guiding human research, including FDA and OHRP guidelines