Coordinator II, Quality Control

Job Overview Summary

This role conducts Quality Control (QC) activities on IRB and staff documentation to ensure accuracy compared to primary sources and adherence to all applicable Advarra quality control standards, federal regulations, and timelines. Requires independent judgment, attention to detail and accountability. Works with the Manager and leadership team to identify strategies and methods to achieve organizational goals.

Job Duties & Responsibilities

• Effectively performs the duties of a 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 eConsent 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

Location

This role is open to candidates working remotely in the United States.

Basic Qualifications

• Bachelor’s degree in health science or related field, or equivalent combination of education and experience
• One (1)+ year(s) 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
• Familiar with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom, and web-based proprietary software

Physical and Mental Requirements

• Sit or stand for extended periods of time at stationary workstation
• Regularly carry, raise, and lower objects of up to 10 Lbs.
• Learn and comprehend basic instructions
• Focus and attention to tasks and responsibilities
• Verbal communication; listening and understanding, responding, and speaking