Coordinator II, Quality Control

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

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.

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.

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.

• Effectively performs the duties of a Quality Control CoordinatorII,demonstrating strong attention to detail,andsound 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 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 ore Consent requests). Also performs quality control on study level Protocol or Product Information modifications that do notimpact
  
  Informed Consent templates.
• Performs other duties as assigned

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

• 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…