Similar Jobs
See allClinical Research Associate - FSP - Remote
ICON
ICH-GCP
Regulatory Compliance
Communication
Associate Director of Research Administration
Harvard University
US
Negotiation
Compliance
Communication
Senior Clinical Research Associate
CoMind
US Eastern Time Zone
GCP
ICH
EDC
Central Monitor II
Syneos Health
Mexico
MS Excel
Analytical Skills
Research Administrator, Post-Award II - School of Medicine
Emory University
US
Financial Analysis
MS Office Suite
PeopleSoft
Responsibilities:
- Review HSR and NRD submissions, providing timely and specific feedback and recommending decisions.
- Meet with project teams to ensure clear understanding of changes needed for quality submissions.
- Support development and implementation of data management plans.
Deliverables:
- Completed reviews with documented feedback and defensible determinations.
- Improved submission quality reducing revision cycles.
- Verified adherence to data compliance during closeout.
Qualifications:
- Advanced degree in public health, statistics, or related field.
- 5-7 years progressive experience in research compliance for international settings.
- In-depth knowledge of US IRB exemption categories and USG regulations.
Jhpiego
Jhpiego is a nonprofit global health organization affiliated with Johns Hopkins University, focused on improving the health of women and families. With a global presence, it operates in challenging environments across Africa, Asia, and Latin America, emphasizing research compliance and program learning.