Coordinator , Quality Control

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Remote - U.S.A
United States of America, 000000, USA

• Quality Control CF
• Full-Time
• Requisition #: COORD
  004775

Company Information

At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health.

With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarrabreaksthe silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.

Company Culture

Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.

At Advarra, weseekto foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra; we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.

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 todetailand accountability. Works with the Manager and leadership team toidentifystrategies and methods to achieve organizational goals.

Job Duties & Responsibilities

• Effectively performs the duties of a Quality Control Coordinator,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 staffregardingmissing 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 throughtimelyprocessing of delegated tasks,appropriate escalation of workflow concerns, and proactive process improvement suggestions
• Participates in team and department professional and personal development initiatives whilemaintaininga high levelof integrity through cooperative and respectful interactions with colleagues
• Performs quality control of recruitment, subject facing, translated and generic material submissions as well as site modifications (e.g., Change of Investigator, Sub-Investigator, Location, or Informed Consents; HIPAA ore Consent requests)
• Performs other duties as assigned

Location

This role is open to candidatesworkingremotely inthe United States.

Basic Qualifications

• Bachelor’s degree in health science or related field, or equivalent combination of education and experience
• One (1)+year of experience in an office environment, preferably in a regulated industry
• Basic knowledge of Federal laws and guidelines pertaining to Human Subjects Research Protection
• Proficien…