Regulatory Research Specialist

Ascension•Carmel, IN

3d•Onsite

About The Position

Ascension St. Vincent Heart Center is seeking a Regulatory Research Specialist to join their Regulatory Research department. This is a full-time position, Monday to Friday, days. The specialist will be responsible for creating and submitting regulatory documentation for research studies, coordinating and preparing regulatory submissions, recommending policy changes based on regulatory developments, researching and disseminating information on research trends, and collaborating on regulatory issues such as adverse events and human subject participation.

Requirements

High School diploma equivalency with 2 years of cumulative experience OR Associate's degree/Bachelor's degree OR 4 years of applicable cumulative job specific experience required.
Research Professional preferred.

Nice To Haves

2 or 3 years regulatory research experience in a hospital environment.

Responsibilities

Create and submit all required regulatory submissions related to research studies conducted by the organization.
Coordinate, prepare, review, and submit required regulatory documentation.
Review and recommend changes to departmental policies, procedures and standards commensurate with regulatory developments.
Review and research pertinent trends, issues, and developments in research and disseminate information to staff. Maintain regulatory references and materials.
Collaborate on the management of regulatory-related issues including serious adverse events and human subject participation.