Research Regulatory Specialist II

Job Summary

To support research operations, the full-time salaried Research Regulatory Specialist II will manage regulatory compliance for clinical trials, maintain essential documentation, and assist with submissions to the FDA, all while working fully remote.

Key responsibilities

• Ensure compliance with federal regulations and ICH/GCP guidelines for all regulatory documents related to clinical research
• Assist in the preparation and submission of research protocols, informed consent documents, and required reports to the FDA
• Maintain accurate records and facilitate communication among study teams, investigators, and regulatory bodies to ensure protocol adherence and patient safety

Required qualifications

• 5+ years of experience in the research regulatory field within a clinical research or scientific setting
• Knowledge of U.S. Code of Federal Regulations related to research conduct and the regulatory submission process
• Experience in submitting and maintaining essential regulatory documents for clinical trials
• Proficient in electronic management systems for research, such as IRBNet and clinical trials management systems
• Bachelor's degree in a healthcare-related field or biological sciences preferred