Coordinator I, IRB Support

About this role

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 This position provides administrative IRB Support services to the Boards in the preparation and management of high-quality board meeting minutes. This position will also offer general administrative support as requested of the IRB Support Team. Job Duties & Responsibilities Attend IRB Meetings as assigned and draft meeting minutes: Attend at least two IRB meeting per week, more when business needs require, and prepare draft minutes of IRB meetings using tools such as Zoom, WebEx, and SharePoint Prepare for IRB meetings by conducting a pre-review of the assigned agenda to ensure all regulatory requirements are accurately identified for each submission by utilizing internal support documents, such as the pre-review checklist and minutes notes document Collaborate with the Meeting Coordinator and the Board Chair prior to the IRB meeting to review assigned agenda items to identify any questions or concerns with the regulatory requirements, as needed Record meeting minutes in a timely manner, generally sending for IRB Support QC review within 4 business days of the IRB meeting, focusing on documentation of controverted issues identified during the IRB meeting, compliance with IRB policies and procedures, standard operating procedures and Meeting Minutes template and work instructions, Proofread and edit final IRB meeting minutes to ensure accuracy Collaborate with the Board Chair to edit and finalize IRB meeting minutes in a timely manner Provide IRB meeting attendance coverage for other IRB Support Coordinators as needed Maintain meeting minutes compliance with U.S. and/or Canadian Regulations and Guidelines in the area of Human Subjects Protections Complete standard Human Subjects Research Protections Training, such as CITI, on a repeated cycle as determined by management Complete organizational training as determined by management Assist in IRB Support Department and Company projects as they relate to the IRB Support Team Offer process improvement initiatives to management, as applicable Other duties as assigned Location This role is open to candidates working remotely in the United States. Basic Qualifications Bachelor’s Degree or Associates Degree 2+ years industry or office experience Preferred Qualifications 1 year of IRB or Clinical Research Industry experience Basic knowledge of Federal laws and guidelines pertaining to Human Subjects Protections Research Must be detail-oriented and possess problem solving skills Ability to communicate effectively in English, both verbal and in written Effective written communication skills, including ability to summarize complex discussions Excellent interpersonal

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