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
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.
