Clinical Research Coordinator II - RI Emer Medicine

Clinical Research Coordinator II - RI Emer Medicine Requisition ID 2024-52996 Category Research Overview The Clinical Research Coordinator II is responsible for managing all of the elements of a clinical study in order to meet all protocol obligations while following ICH/GCP guidelines; and departmental/institutional standard operating procedures. These elements include but are not limited to; start-up activities, launch activities, day to day management of a study and study closure activities. The CRC II also trains and mentors other CRC?s to ensure consistency in study management activities. Why Nationwide Children's Hospital? The moment you walk through our doors, you feel it. When you meet our patient families, you believe it. And when you talk with anyone who works here, you want to be part of it. Welcome to Nationwide Children's Hospital, Where Passion Meets Purpose. Here, Diversity, Equity and Inclusion are integrated into our core values and practices. We are passionate about building, sustaining and evolving an inclusive and equitable environment. We are seeking individuals who live these values and want to share their experiences and efforts in support of our collective mission. We're 14,000 strong. And it takes every one of us to improve the lives of the kids we care for, and the kids around the world we'll never meet. Kids who live healthier, fuller lives because of the knowledge we share. We know it takes a Collaborative Culture to deliver on our promise to provide the very best, innovative care and to foster new discoveries, made possible by the most groundbreaking research. Anywhere. Ask anyone with a Nationwide Children's badge what they do for a living. They'll tell you it's More Than a Job. It's a calling. It's a chance to use and grow your talent to make an impact that truly matters. Because here, we exist simply to help children everywhere. Nationwide Children's Hospital. A Place to Be Proud. Responsibilities Performs research activities as outlined in study protocols; screen, approach, consent and collect data according to protocol Provides in-person and electronic updates to EM Team Lead and Study PIs (as needed) Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management Assists in the development and implementation of study trainings and is able to provide assistance to EM Research Team members during training periods Acts as a peer reviewer for data collection completed by EM Research Team Ensures protection of human subjects' rights through IRB regulations Responsible for regulatory/IRB issues after a study has been initiated by the study sponsor Creates IRB submissions for study oversight including but not limited to Study Modifications, Continuing Reviews, and External Updates Communicates any concerns or questions with the EM Team Lead, EM Research Project Manager, EM Research Director and Study PIs as needed Assists the EM Team Lead to delegate study tasks to EM Research Team members All other duties as assigned Qualifications Reports to: EM Research Coordinator Team Lead Master's degree preferred Experience with informed consent/ research enrollment Some evening and weekend hours required Excellent communication and organizational skills to effectively interact with medical staff, consultants, external professionals, administrators, and employees at all levels. Excellent skills in writing, communications, and presentation graphics knowledge required Knowledge and experience in study management preferred Significant contact with medical staff, outside vendors and community representatives Minimum physical requirements: Talking on phone/in