
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.
🔥 13 hours 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.
• Conduct accurate pre-reviews of new and revised consent forms for regulatory compliance with FDA, HHS, Health Canada, TCPS2, ICH GCP, and Advarra procedures • Edit new and revised consent forms to meet regulatory standards and Advarra document requirements • Incorporate negotiated Sponsor language into consent forms according to client agreements • Collaborate with Board members and staff to incorporate stakeholder edits • Maintain and enhance knowledge of U.S. and/or Canadian regulations and guidelines for human subject protections, drug, device, and cosmetic research • Attend at least one IRB meeting monthly, or two monthly during initial training • Offer process-improvement suggestions to management • Perform other assigned duties
• 1+ 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 • 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 as required • Completion of standard Human Subjects Research Training, such as CITI, on a recurring cycle determined by management • Fulfillment of organizational training requirements as directed by management • 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 eligibility in addition to base salary • Health coverage • Paid holidays • Reasonable accommodation for applicants with disabilities • Inclusive and collaborative workplace environment
Apply Now🔥 13 hours ago
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