Sr Coordinator, Meeting Coordination

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  

Manages the IRB meeting workflow by reviewing incoming submissions, assigning reviews to Board members, coordinating IRB meeting space/platform, and preparing informed consent forms (ICFs) in adherence to all applicable federal regulations. 

Job Duties & Responsibilities 

• Facilitate communication between Client Services, Board reviewers, and Client  

• Prepare Meeting/Post meeting ICFs reflecting Board concerns and edits 

• Prepare proposed meeting determinations for Chair review 

• Host web platform for IRB meetings 

• Provide pre-and during-meeting support to Chairs and Board Members for regulatory compliance 

• Manage complex issues arising during IRB meetings 

• Identify and address issues needing attention by the IRB and Chair 

• Challenge or clarify opinions and questions during IRB meetings 

• Collaborate with client services on reporting special issues to the IRB 

• Analyze and recommend improvements to IRB review methods 

• Conduct accurate pre-reviews of consent forms for regulatory compliance 

• Edit consent forms to align with regulatory standards and Advarra operational guidelines 

• Apply negotiated language to consent forms as per client agreements 

• Collaborate with stakeholders to incorporate necessary edits 

• Perform quality control checks on consent forms 

• Stay updated on U.S. and/or Canadian Regulations and Guidelines in Human Subject Protections and research areas 

• Complete standard Human Subjects Research Training, e.g., CITI, as per management's cycle 

• Fulfill organizational training requirements 

• Attend conferences, webinars, workshops as agreed upon with management 

• Manage IRB meetings weekly on average over additional Board meetings as requested by management 

• Mentor new team members upon request 

Location