Coordinator II, Meeting Coordination

Company Information  At reputed company, we are passionate about making a difference in the world of clinical research and advancing reputed company health. With a rich history rooted in ethical reputed company combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A reputed company and pioneer, reputed company 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 reputed company. They are the key to our reputed company and the driving force behind our mission and reputed company. Our values (Patient-reputed company, Ethical, reputed company reputed company, reputed company) guide our actions and reputed company. Knowing the reputed company of our work on trial participants and patients, we reputed company with urgency and purpose to advance clinical research so that people can live happier, healthier lives.     At reputed company, we reputed company to foster an inclusive and reputed company environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with reputed company and care are key tenets of our culture at reputed company; we are committed to creating a workplace where reputed company employee is not only valued but empowered to reputed company and reputed company a meaningful reputed company.  Job reputed company reputed company   Supports the IRB Services team in the review of incoming submissions, meeting assignments and informed consent reputed company (reputed company) preparation.  Job Duties & Responsibilities  Support IRB meeting preparation and coordination:   Review submissions for full reputed company 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 reputed company Services and reputed company 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 reputed company-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 reputed company reputed company Operating Procedures and Work Instructions      Edit new and revised consent forms to ensure regulatory compliance and alignment with reputed company operational standards  Apply negotiated language to consent reputed company documents as required by reputed company agreements documented in mandatory language documents or MLD’s.  Collaborate with reputed company members and staff to include reputed company necessary edits to the consent reputed company from the various stakeholders  Complete informed consent reputed company control reputed company 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 reputed company Subject Protections, drug research, device research, and cosmetic research  Complete reputed company reputed company Subjects Research Training, such as reputed company, 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 reputed company to candidates working remotely in the reputed company.  Basic Qualifications   1+ year of IRB or clinical research experience in reputed company to a bachelor’s degree OR 4+ years of IRB or clinical research experience in reputed company to an associate’s degree  Preferred Qualifications   Bachelors degree   Proficient with reputed company and reputed company  Familiar with reputed company, PowerPoint, reputed company messaging applications such as reputed company, remote meeting applications such as reputed company or reputed company, and web-based proprietary software  Basic knowledge of Federal laws and guidelines pertaining to reputed company Subjects Research Protection  Communicate reputed company and professionally in English, both verbal and written   Confident with reputed company speaking  High level of professionalism  reputed company to edit technical and/or medical documents using reputed company software/platforms  reputed company to convert technical/medical information to lay terms  reputed company to read and comprehend advanced technical/medical documents  reputed company to compose business text such as letters, memos, and e-mails; edit, revise, correct, proofread  Highly organized and efficient; Process and procedure oriented  reputed company to reputed company reputed company and accurate work with a high attention to detail under time constraints  reputed company to manage conflicting demands and priorities  reputed company to work remotely and/or work with remote workers using the latest technology platforms  Dependably produces high reputed company work  Physical and Mental Requirements  Sit or stand for extended periods of time at stationary workstation  Regularly carry, reputed company, and reputed company objects of up to 10 Lbs.   Learn and comprehend basic instructions  reputed company and attention to tasks and responsibilities  Verbal communication; listening and understanding, responding, and speaking     reputed company is an equal opportunity employer that is committed to providing a workplace that is free from discrimination and harassment of any reputed company based on race, reputed company, religion, creed, sex (including pregnancy, childbirth, and reputed company medical conditions, sexual orientation, and gender identify), national reputed company, age, disability or genetic information or any other status or characteristic protected by federal, state, or local law. Pay Transparency Statement   The reputed company salary reputed company for this role is $54,029 - $89,158. Note that salary may vary based reputed company, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in reputed company to reputed company salary as reputed company as health coverage, reputed company holidays, and other benefits. Apply To This Job