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: Review submissions for full board assignment to ensure they are ready for evaluation.

• Allocate submissions to scheduled IRB meetings as instructed.

• Communicate assignments and updates to reviewers via CIRBI.

• Facilitate clarifications 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 generation of meeting determinations in conjunction with the Senior Meeting Coordinator.

• Conduct thorough pre-reviews of new and revised consent forms to ensure compliance with relevant FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational 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.

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

• Collaborate with Board members and staff to integrate all necessary edits to the consent forms from various stakeholders.

• Execute informed consent quality control checks for oneself and others.

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

• Continuously update knowledge of 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 established by management.

• Fulfill organizational training requirements as directed by management.

• Participate in at least four IRB meetings per month to deepen understanding of IRB processes.

• Propose process improvement ideas to management.

• Perform other assigned duties.

⛳️ Requirements

• Minimum of 1 year of IRB or clinical research experience alongside a bachelor’s degree OR at least 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 tools like Slack, remote meeting platforms such as Zoom or RingCentral, and proprietary web-based software.

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

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

• Confident in public speaking.

• High level of professionalism.

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

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

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

• Skilled in composing business correspondence such as letters, memos, and emails; including editing, revising, correcting, and proofreading.

• Highly organized and efficient; oriented towards processes and procedures.

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

• Capable of managing conflicting demands and priorities.

• Comfortable working remotely and/or collaborating with remote colleagues using the latest technology platforms.

• Consistently produces high-quality work.

🏝️ Benefits

• Health coverage.

• Paid holidays.

• Variable bonus.