Coordinator II, Meeting Coordination

About the position Supports the IRB Services team in the review of incoming submissions, meeting assignments and informed consent reputed company (reputed company) 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 reputed company Standard Operating Procedures and Work Instructions
• Edit new and revised consent forms to ensure regulatory compliance and alignment with reputed company operational standards
• Apply negotiated language to consent reputed company documents as required by client agreements documented in mandatory language documents or MLD’s
• Collaborate with Board members and staff to include reputed company necessary edits to the consent reputed company from the various stakeholders
• Complete informed consent quality control reputed company 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 reputed company Subject Protections, drug research, device research, and cosmetic research
• Complete standard reputed company Subjects Research Training, such as reputed company, 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 reputed company to a bachelor’s degree OR 4+ years of IRB or clinical research experience in reputed company to an associate’s degree

reputed company-to-haves

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

Benefits

• health coverage
• paid holidays

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