Senior Editor - Informed Consent & IRB Compliance (Remote)

Advarra; Northern (KY); Hybrid; USD 67,000 - 116,000; Full time

Job summary

Advarra is seeking a Sr Editor, Consent Form Development to support the IRB Services department in reviewing submissions and preparing informed consent forms used in human subjects research. The Senior Editor may mentor new editors and complete projects as defined by management.

Role requires staying current with FDA/ICH guidelines, applying sponsor language, and ensuring high-quality documents. Remote US-based work is available, with periodic IRB meeting attendance and ongoing training.

Qualifications

• 2+ years of experience in technical/medical writing and/or editing
• Experience writing and/or editing consent forms or other research documents
• Proficiency in Word processing and editing (Tracked Changes and Compare Merge)

Responsibilities

• Conduct accurate pre-review of new and revised consent forms for regulatory compliance
• Edit consent forms to ensure regulatory compliance and alignment with Advarra standards
• Apply sponsor/site language to consent forms as required by client agreements
• Collaborate with Board members and staff to include necessary edits from stakeholders
• Complete informed consent quality control checks for self and others
• Mentor new team members as requested
• Maintain and increase knowledge of US/Canada regulations governing human subjects protections
• Complete standard Human Subjects Research Training such as CITI on a rotating basis
• Attend IRB meetings (1 per month, 2 during initial training)
• Offer process improvement suggestions to management
• Perform other duties as assigned

Skills

Technical writing

Editing

Education

Bachelor's degree

Tools

Microsoft Word

Excel

PowerPoint

Slack

Zoom

Job description

Advarra is seeking a Sr Editor, Consent Form Development to support the IRB Services department in reviewing submissions and preparing informed consent forms used in human subjects research. The Senior Editor may mentor new editors and complete projects as defined by management.

Role requires staying current with FDA/ICH guidelines, applying sponsor language, and ensuring high-quality documents. Remote US-based work is available, with periodic IRB meeting attendance and ongoing training.