Coordinator II, Meeting Coordination

Advarra

Supports the IRB Services team in meeting preparation, review of submissions, and informed consent form preparation. Tasks include regulatory compliance checks and collaboration with various stakeholders.

Posted 6/25/2026full-timeRemote • 🇺🇸 United StatesJunior💰 $54,029 - $89,158 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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
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

Comp & perks

Health coverage
Paid holidays
Variable bonus

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

IRB experienceclinical research experienceregulatory complianceediting technical documentsinformed consent quality controlHuman Subjects Research Trainingknowledge of FDA regulationsknowledge of HHS regulationsknowledge of Health Canada regulationsknowledge of ICH GCP guidance

Soft Skills

clear communicationpublic speakingprofessionalismattention to detailorganizational skillsefficiencyability to manage prioritiesability to work under time constraintscollaborationprocess improvement

Certifications

CITI certification