Job Overview Summary 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.
Job Duties & 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
Location This role is open to candidates working in the United States
Basic Qualifications - 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
Preferred Qualifications - Certified IRB Professional (CIP) or attainment within one (1) year of eligibility
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
The base salary range for this role is $66,767 - $116,089. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.
