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

Basic Qualifications  

2+ years IRB experience in addition to a bachelor’s degree; 
or a combination of education and experience  

Certified IRB Professional (CIP) or attainment of CIP within one (1) year of eligibility 

Preferred Qualifications  

Advanced knowledge of Federal laws and guidelines pertaining to Human Subjects Research Protection  

Proficient with MS Word and Outlook 

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  

Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by federal, state, or local law.  Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment. 

Pay Transparency Statement  
The base salary range for this role is $66,767 - $116,089. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.