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The Department of Obstetrics and Gynecology is seeking a Regulatory Specialist to join their exceptional team!
The Regulatory Specialist will support the Human Subjects Core (HSC) to support clinical research studies conducted by Ob/Gyn and Pediatric faculty and researchers at Unity Point Health-Meriter. The Regulatory Specialist assists in all regulatory activities including reviewing documents, applications, and reports and ensuring compliance with internal and external regulatory framework.
SMPH is committed to being a diverse, equitable, inclusive and anti-racist workplace and is an Equal Employment Opportunity, Affirmative Action employer. Applications from Black, Indigenous and People of Color (BIPOC) individuals, LGBTQ+ and non-binary identities, women, persons with disabilities, military service members and veterans are strongly encouraged.
Assists in all regulatory activities including reviewing documents, applications, and reports and ensuring compliance with internal and external regulatory framework.
- 15% Ensures compliance with all regulations and laws pertaining to unit’s business
- 65% Compiles and maintains appropriate documents for regulatory submissions
- 10% Conducts research to support regulatory submissions
- 10% Prepares and submits documentation to regulatory agencies
- Prior experience with Institutional Review Board (IRB) application process preferred.
- Experience in a medical, research or educational setting strongly desired.