Remote Quality Control Coordinator II — IRB & Study Docs

Advarra; Northern (KY); Hybrid; USD 54,000 - 89,000; Full time

Benefits offered by this job

Health coverage

Paid holidays

Other benefits

Job summary

Advarra is seeking a Quality Control Coordinator II to perform QC on IRB and staff documentation, ensuring accuracy against primary sources and compliance with Advarra standards and federal regulations. The role requires independent judgment, attention to detail, and collaboration with the Manager and leadership to meet organizational goals.

The ideal candidate has a Bachelor’s degree in health science or related field and at least 1 year of IRB/clinical research or quality control experience,

Qualifications

• Bachelor’s degree in health science or related field or equivalent experience.
• 1+ year 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.
• Familiar with Excel, PowerPoint, Slack, Zoom, and web-based proprietary software.

Responsibilities

• Effectively performs the duties of the Quality Control Coordinator II, demonstrating strong attention to detail and sound judgment.
• Reviews and critically analyzes documents for accuracy in content for assigned submission types.
• Provides clear feedback to communicate errors to Research Services staff regarding missing and/or incomplete elements.
• Accomplishes daily workload priorities with flexibility and adaptability.
• Executes procedures in compliance with internal quality standards and external regulations.
• Support supervisor or director vision of team performance through timely processing of delegated tasks, appropriate escalation of workflow concerns, and proactive process improvement suggestions.
• Participates in team and department professional and personal development initiatives while maintaining a high level of integrity through cooperative and respectful interactions with colleagues.
• Performs quality control of recruitment, subject facing, translated and generic material submissions as well as initial site reviews and site modifications (e.g., Change of Investigator, Sub-Investigator, Location, Disclosure of Conflict of Interest, or Informed Consents, including propagated modifications; HIPAA or Consent requests). Also performs quality control on study level Protocol or Product Information modifications that do not impact Informed Consent templates.
• Performs other duties as assigned

Skills

Attention to detail

Time management

Verbal communication

Teamwork

Education

Bachelor’s degree in health science or related field

1+ year IRB/clinical research/quality control experience

Tools

MS Word

Outlook

Excel

PowerPoint

Slack

Zoom

web-based proprietary software

Job description

Advarra is seeking a Quality Control Coordinator II to perform QC on IRB and staff documentation, ensuring accuracy against primary sources and compliance with Advarra standards and federal regulations. The role requires independent judgment, attention to detail, and collaboration with the Manager and leadership to meet organizational goals.

The ideal candidate has a Bachelor’s degree in health science or related field and at least 1 year of IRB/clinical research or quality control experience,