Senior IRB & Research Compliance Advisor

Johns Hopkins University; Baltimore (MD); On-site; USD 45,000 - 56,000; Part time

Job summary

Jhpiego is seeking a Senior Technical Advisor to lead compliance reviews of human subjects research and non-research determinations. You will guide project teams on study design, data management, and closeout to ensure alignment with JH U/Jhpiego policies and national regulations.

The role involves providing expert input to the IRBHelp team, timely feedback, and the development of data management plans across multiple projects, ensuring rigorous and compliant learning activities.

Qualifications

• In-depth knowledge of US IRB exemption categories (45 CFR 46) and use for providing advice and determinations.
• Strong technical background in IRB and Research Compliance, including management and support.
• Experience in regulatory and ethical review of research protocols and non-research determinations.
• Knowledge of research compliance monitoring techniques.
• Experience designing research compliance monitoring.
• Experience in implementation research using quantitative and qualitative methods.

Responsibilities

• Review HSR and NRD submissions to IRB Help with timely, clear feedback and defensible determinations.
• Provide concrete feedback to project teams to improve submission quality.
• Support development of data management plans ensuring rigorous data handling per policies.
• Assist with data compliance during project closeout and proper data storage/disposition.
• Coordinate with IRBHelp team and maintain submission tracking and reporting on review status.

Skills

IRB knowledge

Regulatory review

Data management

Donor compliance

Education

Master's degree in Health Policy

Doctoral degree preferred

Job description

Jhpiego is seeking a Senior Technical Advisor to lead compliance reviews of human subjects research and non-research determinations. You will guide project teams on study design, data management, and closeout to ensure alignment with JH U/Jhpiego policies and national regulations.

The role involves providing expert input to the IRBHelp team, timely feedback, and the development of data management plans across multiple projects, ensuring rigorous and compliant learning activities.