Sr Coordinator, Quality Control

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, Advarra breaks the 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, we seek to 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 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