Clinical Research Safety Specialist - Remote US

Key Responsibilities

• Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other applicable oversight bodies.
• Maintain and organize IND Safety Reports, Investigator Brochures, and other essential regulatory documentation.
• Monitor and support compliance with federal regulations, sponsor requirements, and institutional policies.
• Aid in regulatory submissions and ongoing regulatory affairs activities for industry-sponsored and investigator-initiated clinical trials.
• Partner with Regulatory Affairs leadership, study teams, and Principal Investigators to ensure regulatory requirements are met.
• Support audit and inspection readiness by maintaining complete, accurate, and current regulatory files.
• Track deadlines and manage multiple priorities while ensuring timely completion of submissions and compliance-related activities.

Qualifications

• Bachelor's Degree required
• Minimum 1+ years' professional work experience in a clinical research, biotechnology, life sciences, pharmaceutical or hospital environment
• Work experience should include knowledge of IRB, FDA, and GCP guidelines
• Work experience of scientific and clinical research terminology required
• Above average skills with all MS Office products including Excel, Word, Outlook
• Exceptional organizational skills required