Regulatory Operations Assistant

📋 Description

• Maintain ISFs for assigned studies, incl. IRB submissions/approvals
• Manage Delegation of Authority logs and related systems
• Obtain investigator signatures and distribute docs
• Process IND Safety/SUSAR reports with IRB/files
• Coordinate monitor visits and monitor logs
• Maintain training docs and investigator credentials

🎯 Requirements

• High school diploma or equivalent
• Proficient with Microsoft Word and general computer skills
• Excellent organizational skills, detail-oriented
• Strong writing, proofreading, and document-review ability
• Independent worker, follows processes accurately
• Clear, professional communication with stakeholders

🎁 Benefits

• $22–$24 per hour; remote position
• Full-time, remote work
• Mon–Fri, 8:00 AM–4:30 PM EST
• 401(k) with company match; performance bonus
• PTO and paid holidays; health/dental/vision
• Life and disability insurance; EAP