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Clinical Research Operations Manager Requisition ID 2024-53792 Category Research Overview General Description: Responsible for managing all activities associated with the day to day management of CGT Clinical Operations; personnel and resource management and must ensure that all operations related to the implementation and execution of clinical research projects, programs, business, and departmental training/compliance functions meet all protocol obligations while following applicable regulations; Code of Federal Regulations Good Clinical Practices (GCP) and International Conference on Harmonization GCP guidelines; state regulations and departmental/institutional standard operating procedures. In partnership with the Administrative Director, the Clinical Research Operations Manager ensures all patients involved in a clinical research trial in CGT Operations are managed uneventfully, safely, and as effectively as possible through their episode of care and participation in the clinical research trial, ensuring patient care is not compromised while participating in a clinical research trial. 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 Essential Job Functions Directly responsible for the management and oversight of clinical research with the clinical research/inpatient/outpatients spaces and all clinical research projects conducted to ensure compliance with all applicable hospital and research regulations and policies, protection of human subjects, high quality data collection and effective study enrollment and completions responsive to all investigators within the Center for Gene Therapy in assisting with the development of their clinical research pipeline. Manages all human and physical resources associated CGT Clinical Research Operations. Works with the GCT Training/Compliance and Regulatory Teams on the development and implementation of quality and training standards for clinical operations staff; Responsible for planning and assigning staff to various studies, making organizational and/or resource adjustments as appropriate; Ensures adequate level of staff training to meet performance and quality standards; Responsible for hiring, performance evaluations and firing of clinical research operations staff in coordination with Team Leads. Provides guidance/oversight to clinical team members in all aspects of clinical study coordination as well as patient safety; troubleshoots clinical study issues including those issues that hav