
501 - 1000 employees
Founded 1983
💼 Consulting
📦 Logistics
📣 Marketing
Consulting • Logistics • Marketing
Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.
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501 - 1000 employees
Founded 1983
💼 Consulting
📦 Logistics
📣 Marketing
Consulting • Logistics • Marketing
Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.
• Conduct accurate pre-review of new and revised consent forms for regulatory compliance with FDA, HHS, Health Canada, TCPS2, and ICH GCP requirements and Advarra procedures • Edit new and revised consent forms for regulatory compliance and alignment with Advarra standards • Apply negotiated sponsor and site language documented in mandatory language documents • Collaborate with Board members and staff to incorporate necessary stakeholder edits • Complete informed consent quality-control checks for personal and team documents • Mentor new team members as requested • Maintain and increase regulatory knowledge related to human subject protections, drug, device, and cosmetic research • Complete recurring Human Subjects Research Training, such as CITI • Complete organizational training as required • Attend one IRB meeting monthly, or two monthly during initial training • Offer process-improvement suggestions to management • Perform other duties as assigned
• 2+ years of experience in technical/medical writing and/or editing • Bachelor’s degree • Experience writing and/or editing consent forms or other research documents • Proficiency in word processing and editing, including Tracked Changes and Compare Merge functions • Familiarity with Excel, PowerPoint, Slack or similar direct messaging applications, Zoom or RingCentral or similar remote meeting applications, and web-based proprietary software • Ability to communicate clearly and professionally in English, verbally and in writing • Preferred: 1+ years of IRB experience • Preferred: Certified IRB Professional (CIP) or completion of CIP within two years of eligibility • Knowledge of U.S. and/or Canadian regulations and guidelines concerning human subject protections, drug research, device research, and cosmetic research • Familiarity with scientific/medical terminology and ability to convert scientific/medical information to lay terms • Ability to edit technical and/or medical documents • Ability to read and comprehend advanced technical/medical documents, including medical protocols and informed consent forms • Ability to manage multiple editing projects under conflicting demands and priorities • High attention to detail, accuracy, thoroughness, and problem-solving skills • Ability to follow written and verbal instructions and work independently • Must be able to sit or stand for extended periods at a stationary workstation • Must regularly carry, raise, and lower objects up to 10 lbs.
• Variable bonus eligibility in addition to base salary • Health coverage • Paid holidays • Other benefits
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