Quality Control Coordinator II

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $54k - $89.1k / year

⏰ Full Time

🟢 Junior

👻 Ghost score 0%

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Logo of Advarra

Advarra

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.

📋 Description

• Conduct Quality Control activities on IRB and staff documentation to ensure accuracy against primary sources and compliance with Advarra quality control standards, federal regulations, and timelines • Review and critically analyze documents for accuracy in content for assigned submission types • Communicate clear feedback to Research Services staff regarding missing or incomplete elements • Accomplish daily workload priorities with flexibility and adaptability • Execute procedures in compliance with internal quality standards and external regulations • Support supervisor or director vision of team performance through timely processing of delegated tasks, escalation of workflow concerns, and proactive process improvement suggestions • Participate in team and department professional and personal development initiatives • Perform quality control of recruitment, subject-facing, translated, and generic material submissions • Perform initial site reviews and site modifications, including investigator, location, conflict-of-interest, informed consent, HIPAA, and eConsent requests • Perform quality control on study-level Protocol or Product Information modifications that do not impact Informed Consent templates • Perform other duties as assigned

🎯 Requirements

• Bachelor's degree in health science or related field, or equivalent combination of education and experience • 1+ year of IRB, clinical research, or quality control experience • Basic knowledge of Federal laws and guidelines pertaining to Human Subjects Research Protection • Proficient with MS Word and Outlook • Familiarity with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom, and web-based proprietary software • 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

🏖️ Benefits

• Variable bonus eligibility • Health coverage • Paid holidays

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