Research Regulatory Specialist II
Job Summary
To ensure compliance with regulatory standards, the full-time Research Regulatory Specialist II will manage essential documents, assist with research protocol submissions, and maintain accurate records in a fully remote environment.
Key responsibilities
- Ensure all regulatory documents comply with applicable Federal regulations and ICH/GCP guidelines
- Assist with the submission of research protocols and maintain detailed records throughout the review and approval process
- Coordinate sponsor monitoring visits and ensure effective communication of regulatory updates to relevant stakeholders
Required qualifications
- 5+ years of experience in the research regulatory field in a clinical research or scientific setting
- Working knowledge of U.S. Code of Federal Regulations related to research conduct
- Experience submitting and maintaining regulatory documents, including essential regulatory documents
- Bachelor's degree in a healthcare-related field or biological sciences preferred
- Proficiency in electronic management systems for research, such as IRBNet and CTMS
Complete Job Description
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