
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.
🔥 20 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.
• Manage the IRB meeting workflow by reviewing incoming submissions and assigning reviews to Board members • Coordinate IRB meeting space/platform • Prepare informed consent forms (ICFs) before and after meetings in adherence to applicable federal regulations • Facilitate communication between Client Services, Board reviewers, and clients • Prepare proposed meeting determinations for Chair review • Host the web platform for IRB meetings • Provide pre- and during-meeting support to Chairs and Board Members for regulatory compliance • Manage complex issues arising during IRB meetings • Identify and address issues requiring attention by the IRB and Chair • Challenge or clarify opinions and questions during IRB meetings • Collaborate with Client Services on reporting special issues to the IRB • Analyze and recommend improvements to IRB review methods • Conduct accurate pre-reviews of consent forms for regulatory compliance • Edit consent forms to align with regulatory standards and operational guidelines • Apply negotiated language to consent forms according to client agreements • Collaborate with stakeholders to incorporate necessary edits • Perform quality control checks on consent forms • Manage IRB meetings weekly on average and additional Board meetings as requested • Mentor new team members upon request
• 2+ years of IRB experience • Bachelor’s degree, or a combination of education and experience • Certified IRB Professional (CIP) or attainment of CIP within one year of eligibility • Advanced knowledge of federal laws and guidelines pertaining to Human Subjects Research Protection • Proficiency with MS Word and Outlook • Completion of standard Human Subjects Research Training, e.g., CITI, as required by management • Fulfillment of organizational training requirements • Knowledge of U.S. and/or Canadian Regulations and Guidelines in Human Subject Protections and research areas • Ability to sit or stand for extended periods at a stationary workstation • Ability to regularly carry, raise, and lower objects of up to 10 lbs. • Ability to learn and comprehend basic instructions • Focus and attention to tasks and responsibilities • Verbal communication, listening and understanding, responding, and speaking
• Variable bonus eligibility in addition to base salary • Health coverage • Paid holidays • Reasonable accommodation for applicants with disabilities • Inclusive and collaborative workplace environment • Conferences, webinars, and workshops as agreed upon with management
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💰 Non Equity Assistance on 2016-08
⏰ Full Time
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