Regulatory Research Specialist
On-siteCarmel, Indiana, United States
Job Summary
Create and submit all required regulatory submissions and documentation for research studies conducted by the organization. Coordinate, prepare, and review regulatory materials while reviewing departmental policies to recommend changes commensurate with regulatory developments. Research pertinent trends in research and disseminate information to staff, maintaining regulatory references. Collaborate on managing regulatory-related issues including serious adverse events and human subject participation. This role supports the Regulatory Research department at Ascension St. Vincent Heart Center in Carmel, IN, within a nonprofit Catholic health system reimagining healthcare through service and connection.
Required Qualifications
- High School diploma equivalency with 2 years of cumulative experience
- Associate's degree
- Bachelor's degree
- 4 years of applicable cumulative job specific experience
Desired Qualifications
- Research Professional preferred
- 2 or 3 years regulatory research experience in a hospital environment
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