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
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