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.
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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What We Do
Advarra advances the way clinical research is conducted: bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration. With trusted IRB and IBC review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance.
