Coordinator II, Meeting Coordination

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  

Supports the IRB Services team in the review of incoming submissions, meeting assignments and informed consent form (ICF) preparation. 

Job Duties & Responsibilities  

• Support IRB meeting preparation and coordination:  

• Review submissions for full board assignment to ensure readiness for review 

• Assign submissions to upcoming IRB meetings, as directed 

• Send assignments and assignment updates to reviewers in CIRBI  

• Send clarifications between Client Services and Board reviewers in collaboration with Senior Meeting Coordinator 

• Assist with preparation of Meeting and Postmeeting ICFs, as directed 

• Assist with preparing meeting determinations in collaboration with Senior Meeting Coordinator 

• Conduct an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada,TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions     

• Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standards 

• Apply negotiated language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s. 

• Collaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholders 

• Complete informed consent quality control check for self and others 

• Maintain and increase individual regulatory knowledge to assist with organizational compliance  

• Maintain and increase knowledge of U.S. and/or Canadian Federal Regulations and Guidelines in the area of Human Subject Protections, drug research, device research, and cosmetic research 

• Complete standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management 

• Complete organizational training as required by management 

• Attend a minimum of four IRB meetings per month to enhance knowledge and understanding of IRB processes 

• Offers process improvement suggestions to management 

• Other duties as assigned 

Location  

This role is open to candidates working in one of the following locations: United States and Canada. 

Basic Qualifications 

• Minimum of 1 year of IRB or clinical research experience in addition to a bachelor’s degree, or a minimum of 4 years of IRB or clinical research experience in addition to an associate’s degree 

• Proficient with MS Word and Outlook 

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

• Communicate clearly and professionally in English, both verbal and written  

Preferred Qualifications  

• Familiar with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom or RingCentral, and web-based proprietary software 

• Confident with public speaking 

• High level of professionalism 

• Ablility to edit technical and/or medical documents using current software/platforms, and to convert technical/medical information to lay terms 

• Ability to read and comprehend advanced technical/medical documents 

• Ability to compose business text such as letters, memos, and e-mails; edit, revise, correct, proofread 

• Highly organized and efficient; Process and procedure oriented 

• Proven ability to provide focused and accurate work with high attention to detail under time constraints