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.