About the position Supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs) used in the conduct of human subjects research. In addition, the Senior Editor may mentor new editors and complete projects as defined by management.

Responsibilities

• Conduct an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions
• Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standards
• Apply negotiated Sponsor and site language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s
• Collaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholders
• Complete informed consent quality control check for yourself and others
• Mentor new team members, as requested
• Maintain and increase individual regulatory knowledge to assist with organizational compliance
• Maintain and increase knowledge of U.S. and/or Canadian Regulations and Guidelines in the area of Human Subject Protections, drug research, device research, and cosmetic research
• Complete standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management
• Complete organizational training as required by management
• Attend one IRB meeting per month to enhance knowledge and understanding of IRB processes (two meetings per month during the initial training period)
• Offer process improvement suggestions to management, as applicable
• Other duties as assigned

Requirements

• Minimum of 2 years of experience in technical/medical writing and/or editing in addition to a Bachelor’s degree
• Experience writing and/or editing consent forms or other research documents
• Proficiency in Word processing and editing (including use of Tracked Changes and Compare Merge functions)
• Familiar with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom or RingCentral, and web-based proprietary software

Nice-to-haves

• 1 year of IRB experience
• Experience writing and/or editing consent forms or other research documents
• Certified IRB Professional (CIP) or completion of CIP within two (2) years of eligibility
• Ability to communicate clearly and professional in English, both verbal and written skills
• Excellent interpersonal skills to work professionally and effectively with others and provide high levels of customer service
• In-depth knowledge of matters regarding human subjects research and informed consent
• Familiar with scientific/medical terminology and able to convert scientific/medical information to lay terms
• Ability to edit technical and/or medical documents
• Ability to read and comprehend advanced technical/medical documents such as medical protocols and informed consent forms
• Ability to manage various editing projects under conflicting demands and priorities
• Dependably produces high quality work
• Must have high level of attention to detail, accuracy and thoroughness; problem solving skills
• Ability to follow written and verbal instructions and work independently as required

Benefits

• health coverage
• paid holidays