Regulatory Affairs Specialist
4 days ago
A leading healthcare organization is seeking a highly skilled Regulatory Affairs Specialist to manage and oversee all Institutional Review Board (IRB) and regulatory processes within the Research department. This role is pivotal in ensuring compliance with IRB policies, FDA regulations, and sponsor requirements.
Key Responsibilities:
- Develop and create patient-facing study documents that comply with IRB policies, FDA regulations, and sponsor requirements.
- Serve as the primary contact for IRB-related correspondence, including tracking responses and providing assistance to IRB, sponsors, and research staff.
- Distribute IRB approval documentation and post-meeting information to study sponsors and research staff.
- Assist in ensuring files are continuously updated and prepared for internal and FDA audits.
- Draft, review, and submit informed consents/assents when applicable.
- Review protocols and other study documentation for accuracy and completeness, performing quality control based on standard operating procedures.
- Submit prepared documents in applicable IRB systems, ensuring compliance with Federal and State laws.
Requirements:
- Bachelor's degree in a related field or equivalent experience.
- Prior experience as a Research Coordinator and/or Regulatory Coordinator is strongly preferred.
- Experience working with pharmaceutical-sponsored studies is preferred.
- Proficiency in electronic regulatory systems and Veeva is required.
Compensation:
The estimated salary for this position is $62,500-$92,000 per year, based on industry standards and location.
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