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
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
Location
This role is open to candidates working remotely in the United States.
Basic Qualifications
- 1+ year of IRB or clinical research experience in addition to a bachelor’s degree OR 4+ years of IRB or clinical research experience in addition to an associate’s degree
Preferred Qualifications
- Proficient with MS Word and Outlook
- Familiar with Excel, PowerPoint, direct messaging applications such as Slack, remote meeting applications such as Zoom or RingCentral, and web-based proprietary software
- Basic knowledge of Federal laws and guidelines pertaining to Human Subjects Research Protection
- Communicate clearly and professionally in English, both verbal and written
- Confident with public speaking
- High level of professionalism
- Able to edit technical and/or medical documents using current software/platforms
- Able to convert technical/medical information to lay terms
- Able to read and comprehend advanced technical/medical documents
- Able to compose business text such as letters, memos, and e-mails; edit, revise, correct, proofread
- Highly organized and efficient; Process and procedure oriented
- Able to provide focused and accurate work with a high attention to detail under time constraints
- Able to manage conflicting demands and priorities
- Able to work remotely and/or work with remote workers using the latest technology platforms
- Dependably produces high quality work
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 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 identify), national origin, age, disability or genetic information or any other status or characteristic protected by federal, state, or local law.
Pay Transparency Statement
The base salary range for this role is $54,029 - $89,158. 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.
