Sr. Technical Advisor, Research Compliance (Casual)

Jhpiego•Baltimore, MD

12d•$45 - $56•Remote

About The Position

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.

Requirements

Advanced degree in public health (international health, epidemiology, biostatistics, population), statistics, research, economics, behavioral science, or related field
5-7 years of progressively responsible technical experience including implementing and/or managing Research Compliance for international field-based research and program learning
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
Excellent understanding of USG regulations regarding Federal Wide Assurance (FWA) and reporting to OHRP
Experience in working in challenging environments in Africa, Asia or LAC regions
Proven ability to work in a complex, fast-paced, multi-cultural environment with multiple tasks and short deadlines
Excellent inter-personal and communication skills, including strong technical writing and presentation skills
Prolonged sitting >50% of the time

Nice To Haves

Fluency in French, Spanish or Portuguese

Responsibilities

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.
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.
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.
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.