Sr Coordinator, Quality Control

Advarra

18h•Remote

About The Position

This role conducts Quality Control (QC) activities on complex 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 a high degree of independent judgment, attention to detail and accountability. Works with the Manager and leadership team to identify strategies and methods to achieve organizational goals. Expertise reflected in consideration of continuously improving workflow.

Requirements

Bachelor’s degree in health science or related field, or equivalent combination of education and experience
Intermediate knowledge of Federal laws and guidelines pertaining to Human Subjects Research Protection
Two (2)+ years of IRB, clinical research or quality control experience
Proficient with MS Word, Outlook, and Excel
Familiar with PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom, and web-based proprietary software

Nice To Haves

Certified IRB Professional (CIP) or attainment within one (1) year of eligibility

Responsibilities

Effectively performs the duties of a Senior Quality Control Coordinator, demonstrating strong attention to detail, sound judgment, and the ability to work independently
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
Models QC best practices through peer-to-peer training and mentorship
Serves as a resource for process or workflow problem-solving, including root cause analysis and data mining
Propose and advocate adoption of team success metrics
Provides process improvement suggestions to management
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 all submission types (initial protocol and site submissions, all modifications).
Performs other duties as assigned