
501 - 1000 employees
Founded 1983
🏥 Healthcare
💼 Consulting
☁️ SaaS
Healthcare • Consulting • SaaS
Advarra is a provider of integrated regulatory oversight and clinical trial technology, combining independent IRB review and compliance services with enterprise SaaS platforms (including Braid, OnCore, Clinical Conductor, eReg, and eSource). The company delivers operational intelligence, AI-powered protocol design and automation, site collaboration, study startup and enrollment tools, and strategic enablement services to sponsors, CROs, research sites, and institutions to improve efficiency, compliance, and patient safety across the clinical trial lifecycle.
🔥 10 minutes ago
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501 - 1000 employees
Founded 1983
🏥 Healthcare
💼 Consulting
☁️ SaaS
Healthcare • Consulting • SaaS
Advarra is a provider of integrated regulatory oversight and clinical trial technology, combining independent IRB review and compliance services with enterprise SaaS platforms (including Braid, OnCore, Clinical Conductor, eReg, and eSource). The company delivers operational intelligence, AI-powered protocol design and automation, site collaboration, study startup and enrollment tools, and strategic enablement services to sponsors, CROs, research sites, and institutions to improve efficiency, compliance, and patient safety across the clinical trial lifecycle.
• Support the IRB Services department in reviewing incoming submissions and preparing informed consent forms used in human subjects research • Conduct accurate pre-reviews of new and revised consent forms for FDA, HHS, Health Canada, TCPS2, and ICH GCP regulatory compliance • Edit consent forms for regulatory compliance and alignment with Advarra standards • Apply negotiated sponsor and site language according to client agreements and mandatory language documents • Collaborate with board members and staff to incorporate stakeholder edits • Perform informed consent quality-control checks for self and others • Mentor new team members as requested • Maintain and increase knowledge of U.S. and/or Canadian human-subjects regulations and guidelines • Complete recurring Human Subjects Research Training, such as CITI, and organizational training • Attend one IRB meeting per month, or two per month during initial training • Suggest process improvements 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 • In-depth knowledge of human subjects research and informed consent • 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, such as 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 • Ability to sit or stand for extended periods at a stationary workstation • Ability to regularly carry, raise, and lower objects up to 10 lbs.
• Variable bonus may be available in addition to base salary • Health coverage • Paid holidays • Remote work in the United States
Apply Now🔥 11 minutes ago
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💰 Debt Financing on 2022-06
⏰ Full Time
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