Coordinator II – Meeting Coordination

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the preparation and coordination of IRB meetings by reviewing submissions for full board assignments to ensure they are ready for review.

• Assign submissions to forthcoming IRB meetings as instructed.

• Distribute assignments and updates to reviewers via CIRBI.

• Facilitate communication between Client Services and Board reviewers in collaboration with the Senior Meeting Coordinator.

• Aid in the preparation of Meeting and Postmeeting Informed Consent Forms (ICFs), as directed.

• Support the preparation of meeting determinations in conjunction with the Senior Meeting Coordinator.

• Conduct thorough pre-reviews of new and revised consent forms to ensure compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and adherence to Advarra Standard Operating Procedures and Work Instructions.

• Revise new and updated consent forms to guarantee regulatory compliance and alignment with Advarra's operational standards.

• Integrate negotiated language into consent form documents as stipulated by client agreements in mandatory language documents or MLDs.

• Collaborate with Board members and staff to incorporate all necessary edits from various stakeholders into the consent form.

• Conduct quality control checks on informed consent for yourself and others.

• Enhance and maintain individual regulatory knowledge to support organizational compliance.

• Stay informed about U.S. and/or Canadian Federal Regulations and Guidelines regarding Human Subject Protections, drug research, device research, and cosmetic research.

• Complete standard Human Subjects Research Training, such as CITI, on a recurring cycle as determined by management.

• Fulfill organizational training requirements as mandated by management.

• Attend at least four IRB meetings each month to deepen knowledge and understanding of IRB processes.

• Propose suggestions for process improvements to management.

⛳️ Requirements

• A minimum of 1 year of IRB or clinical research experience alongside a bachelor’s degree, OR 4+ years of IRB or clinical research experience with an associate’s degree.

• Proficient in MS Word and Outlook.

• Familiarity with Excel, PowerPoint, direct messaging applications like Slack, remote meeting platforms such as Zoom or RingCentral, and web-based proprietary software.

• Basic understanding of Federal laws and guidelines regarding Human Subjects Research Protection.

• Ability to communicate effectively and professionally in English, both verbally and in writing.

• Comfortable with public speaking.

• Exhibits a high level of professionalism.

• Capable of editing technical and/or medical documents utilizing current software/platforms.

• Skilled in translating technical/medical information into layman's terms.

• Proficient in reading and understanding advanced technical/medical documents.

• Competent in composing business communications such as letters, memos, and emails; editing, revising, correcting, and proofreading them.

• Highly organized and efficient with a focus on processes and procedures.

• Able to deliver focused and precise work with keen attention to detail under time constraints.

• Capable of managing competing demands and priorities effectively.

• Able to work remotely and interact with remote colleagues using the latest technology platforms.

• Consistently produces high-quality work.

🏝️ Benefits

• Health coverage.

• Paid holidays.

• Variable bonus.