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Johns Hopkins University

Sr. Technical Advisor, Research Compliance (Casual)

baltimore, MD

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Job description

General Summary:

The Senior Technical Advisor will provide leadership, expertise, and high-level technical support for implementation of compliance within both research and program learning. This will include reviewing submissions for human subjects research (HSR) and non-research determinations (NRD) and providing technical guidance to project teams on the design and conduct of these learning activities, ensuring rigorous and compliance data management, and compliant closeout of learning activities. The Senior Technical Advisor will work with Jhpiego's IRBhelp team to ensure timely review and feedback.

DURATION: 07/01/2026 - 06/30/2027

HOURS PER DAY/WEEK: 6 hours per day/ 4 days per week (24 hours per week total)

Specific Duties & Responsibilities:

Regulatory Review & Research Determinations

Review HSR and NRD submissions to IRB Help, providing timely and specific feedback on areas for improvement, and recommend either a decision on whether or not it is research or that it be returned to the team for further revision.

Technical Advisory Support for Submission Quality

Meet with project teams to provide concrete feedback on HSR and NRD submissions to ensure a clear understanding of changes needed to ensure quality submissions.

Data Management Planning

Support project teams in the development of data management plans that ensure rigorous data management in compliance with Jhpiego, JHU and national policies and guidelines. Provide targeted support in implementation of the data management plan.

Data Compliance & Closeout Oversight

Support project teams with ensuring appropriate data compliance during project closeout, ensuring compliance with donor, Jhpiego, JHU and national policies and guidelines. Provide targeted support in implementation of data closeout.

Deliverables:

Complete HSR and NRD reviews with clear, documented feedback and defensible research determinations within agreed timelines.

Deliver of targeted guidance that improves submission quality, reduces revision cycles and facilitates approval by the JHU IRB.

Review and/or develop DMPs that meet Jhpiego, JHU, donor, and national requirements, with documented feedback.

Verify adherence to data compliance requirements during closeout, including proper data handling, storage, and disposition.

Organized data files and metadata available at project closeout.

Provide effective coordination with IRBHelp team, including maintenance of submission tracking and reporting on review status and turnaround times.

Technical Qualifications & Specialized Certifications:

In-depth knowledge of US IRB exemption categories (45 CFR 46) and use for providing advice and making determinations with clarity around program learning activities.

Strong technical background in IRB and Research Compliance especially management, technical support, international research, sociobehavioral learning and other program learning.

Proven technical experience in regulatory and ethical review of research protocols, and making non-research, non-human subject's research determinations.

Knowledge of research compliance monitoring techniques.

Experience in designing research compliance monitoring.

Experience in implementation research, including use of both quantitative and qualitative methods.

Understanding of donor and country government landscape regarding research and data compliance.

Minimum Qualifications

Master's degree in Health Policy or a related field, with Doctoral degree preferred

Seven years related experience in health systems

Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

Doctoral degree in Health Policy or a related field.

Fluency in French, Spanish or Portuguese.

Classified Title: Sr. Technical Advisor

Job Posting Title (Working Title):Sr. Technical Advisor, Research Compliance (Casual)

Role/Level/Range: ACRP/04/MF

Starting Salary Range: $44.65 - $56.18 Commensurate with Experience

Employee group: Casual / On Call

Schedule: Monday - Friday 8:30 am - 5:00 pm

FLSA Status:Exempt

Location:Jhpiego

Department name: -Global Programs and Technical Excellence

Personnel area: Academic and Business Centers

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