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Clinical Research Administrator
2 months ago
Job Summary:
The Regulatory Affairs Specialist - Clinical Research will be responsible for preparing, facilitating, coordinating, and submitting documentation required by federal, state, and local regulations and institutional requirements relating to the conduct of research.
Key Responsibilities:
- Prepare and submit documentation to regulatory agencies and institutional review boards (IRBs) to ensure compliance with federal, state, and local regulations.
- Coordinate and facilitate the preparation of investigator 1572 forms, investigational new drug applications, device submissions, and other regulatory documents.
- Lead the work of research assistants on a task-basis and provide on-the-job training as needed.
- Set priorities and schedules workflow to support project objectives.
Requirements:
- Bachelor's degree in a science, healthcare, or related field, or significant experience in research coordination or regulatory work may be substituted for educational requirements.
- 2 years of experience in healthcare, research, or clinical settings with regulatory compliance familiarity.
About Providence:
Providence is a healthcare organization that values its caregivers and provides a supportive work environment. Our organization is committed to delivering high-quality patient care and improving the health and well-being of our patients.