Coordinator II, Meeting Coordinator
Job Category: IRB
Requisition Number: COORD003495
Full-Time
Remote
Locations
Remote - U.S.A
United States of America, 000000, USA
Job Details
Description
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
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
Time management skills with the ability to manage conflicting demands and priorities
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 $36,200 - $61,500. 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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.
