About the position Supports the IRB Services team in the review of incoming submissions, meeting assignments and informed consent form (ICF) preparation.

Responsibilities

• Support IRB meeting preparation and coordination
• Review submissions for full board assignment to ensure readiness for review
• Assign submissions to upcoming IRB meetings, as directed
• Send assignments and assignment updates to reviewers in CIRBI
• Send clarifications between Client Services and Board reviewers in collaboration with Senior Meeting Coordinator
• Assist with preparation of Meeting and Postmeeting ICFs, as directed
• Assist with preparing meeting determinations in collaboration with Senior Meeting Coordinator
• 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 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 self and others
• Maintain and increase individual regulatory knowledge to assist with organizational compliance
• Maintain and increase knowledge of U.S. and/or Canadian Federal 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 a minimum of four IRB meetings per month to enhance knowledge and understanding of IRB processes
• Offers process improvement suggestions to management
• Other duties as assigned

Requirements

• 1+ year of IRB or clinical research experience in addition to a bachelor’s degree OR 4+ years of IRB or clinical research experience in addition to an associate’s degree

Nice-to-haves

• Bachelors degree
• Proficient with MS Word and Outlook
• Familiar with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom or RingCentral, and web-based proprietary software
• Basic knowledge of Federal laws and guidelines pertaining to Human Subjects Research Protection
• Communicate clearly and professionally in English, both verbal and written
• Confident with public speaking
• High level of professionalism
• Able to edit technical and/or medical documents using current software/platforms
• Able to convert technical/medical information to lay terms
• Able to read and comprehend advanced technical/medical documents
• Able to compose business text such as letters, memos, and e-mails; edit, revise, correct, proofread
• Highly organized and efficient; Process and procedure oriented
• Able to provide focused and accurate work with a high attention to detail under time constraints
• Able to manage conflicting demands and priorities
• Able to work remotely and/or work with remote workers using the latest technology platforms
• Dependably produces high quality work

Benefits

• health coverage
• paid holidays