Sr. Coordinator, Quality Control

Advarra is the premier provider of institutional review board (IRB) services for human subjects research in North America. Fully accredited by AAHRPP, Advarra serves the world's leading pharmaceutical, biotechnology, medical device, and contract research organizations, as well as academic medical centers, health systems, investigative site networks, and therapeutic research consortia.

General Summary:

This role performs complex document quality reviews to ensure accuracy compared to primary sources. Requires high degree of independent judgment and accountability. Expertise reflected in consideration of continuously improving workflow.

Principal Duties & Responsibilities

• Efficiently and effectively perform all of the duties of a Quality Coordinator I, plus:
  • Review and analyze documents for accuracy in content.
  • Communicate errors to operations staff regarding missing and/or incomplete elements.
  • Accomplish daily workload priorities with flexibility and adaptability.
  • Execute procedures in compliance with internal quality standards and external regulations.

• Support manager or director vision of team performance through:
  • Timely processing of delegated tasks;
  • Appropriate escalation of workflow concerns;
  • Modeling QC best practices through peer-to-peer training and mentorship;
  • Serving as a subject matter expert for process or workflow problem-solving, including root cause analysis and data mining;
  • Propose and advocate adoption of team success metrics;
  • Performs other duties as assigned.
  • Participate in team and department professional and personal development initiatives while maintaining a high level of integrity through cooperative and respectful interactions with colleagues.

Education

Associates Degree, or equivalent combination of education and experience

Experience

• 3 years in a human subjects protection environment or related role
• Knowledge of quality control

Knowledge, Skills, Abilities

• Analyze and interpret data
• Communicate clearly and concisely with others, both in writing & verbally, in a professional manner
• Navigate and extract information from information systems
• Complex, critical thinking and problem solving

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

EEO Statement Advarra provides equal employment opportunity to all individuals regardless of their race, color, religion, creed, sex, sexual orientation, gender identity, national origin, age, disability, veteran, marital, or domestic partner status, citizenship, genetic information or any other status or characteristic covered by federal, state or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics.  Discrimination of any type will not be tolerated.   EEO/M/F/Disabled/Vets