Human Subjects Protection Analyst

External Description

Lead the regulatory evaluation of IRB research protocols by the Human Subjects Protection Program. Advise and educate the IRB as well as researchers regarding regulatory, legal, and other requirements of research protocols. Lead various efforts to develop and define the human subjects’ protection program. Make pivotal contributions to research compliance efforts to assess and mitigate research compliance risks. Support various Research Institute initiatives.

Requirements

Required Education/Experience:
- Bachelor's Degree OR significant/applicable college coursework that demonstrates competency
- At least five (5) years of related experience including IRB, medical research, or legal/regulatory experience
- Progressively responsible experience in a professional setting.

Required Credentials:
- N/A

Preferred:
- Juris Doctor from an accredited law school OR PhD or higher level of advanced science degree
- License to practice law in the State of Washington
- Eight (8) or more years of related experience including IRB, medical research, or legal/regulatory experience
- Prior experience with and knowledge of ethical principles, federal regulations, and state law as it pertains to the ethical conduct of human subjects’ research and pediatric research
- Knowledge/experience with FDA-regulated research.


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