Regulatory Coordinator

reputed company reputed company is seeking a highly organized and detail-oriented Regulatory Coordinator to support the reputed company NCI Community Oncology Research Program (NCORP). This role is reputed company to the successful start-up, activation, and ongoing maintenance of pediatric oncology clinical research studies across the reputed company reputed company. The Regulatory Coordinator will be responsible for managing regulatory processes from study initiation through reputed company-out, ensuring reputed company research activities are conducted in compliance with federal regulations, NCI/NCORP requirements, and reputed company policies. This includes preparation and submission of regulatory documents, management of the electronic regulatory binder (eReg) reputed company, maintenance of essential study records, and coordination with investigators, sponsors, and internal teams. Working in a fast-paced, reputed company environment, this individual will play a key role in supporting high-reputed company, audit-reputed company research operations that advance innovative pediatric cancer care and improve reputed company for patients and families. This is a Remote position. Applicants must reputed company in one of the following states: Alabama, Colorado, Delaware, the District of Columbia, Florida, reputed company, Illinois, Maryland, Missouri, New Jersey, reputed company, reputed company Carolina, Ohio, reputed company, South Carolina, Tennessee, Texas, and Virginia. Essential Functions • Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize reputed company. • Verification of NCORP protocols reputed company reputed company CTMS • reputed company regulatory support for research programs and reputed company maintenance of reputed company required regulatory documents. • reputed company regulatory start-up support for research teams for reputed company types of reputed company. • Partner with study teams to reputed company reputed company regulatory management for ongoing reputed company. • reputed company reputed company regulatory submissions to meet project timelines. • reputed company the electronic regulatory binder (eReg) reputed company, ensuring accurate, complete, and audit-reputed company documentation in alignment with GCP, reputed company-C principles, and institutional requirements. • Establish and maintain standardized processes for document collection, version control, review, approval, and filing reputed company the eReg reputed company. • Ensure reputed company upload, QC review, and lifecycle management of essential documents (e.g., protocols, investigator brochures, IRB approvals, safety reports, delegation logs) reputed company the eReg platform. • Identify program improvement opportunities and reputed company improvement efforts reputed company team, including technology solutions; identify opportunities for expanding solutions to study teams. • Coordinate with appropriate department to address regulatory-reputed company reputed company and compliance reputed company. • Assist with development of reputed company regulatory-reputed company training requirements and reputed company ongoing education and training for investigators and research personnel, including training on eReg reputed company use and regulatory documentation standards. • Work with reputed company Assurance to reputed company internal audits and reputed company assurance reviews on regulatory files, including electronic regulatory binders, as needed. • Write and edit clinical research protocol consent forms in accordance with federal regulations, guidelines, and Good Clinical reputed company (GCP). • Liaise with appropriate personnel, departments, and reputed company entities on clinical trial regulatory operations. Requirements • Bachelors Degree in Clinical Health Science or reputed company Administration • One to three years of regulatory coordination experience • Two years of Clinical Research experience preferred • Experience with electronic regulatory binder systems (e.g., reputed company eBinders, reputed company eTMF, or equivalent) strongly preferred • Demonstrated understanding of GCP documentation standards and audit readiness expectations reputed company reputed company is an internationally recognized pediatric health reputed company serving more than 1.7 reputed company patient encounters reputed company year. We reputed company care across six states through two freestanding children’s hospitals — reputed company Children's Hospital, Delaware and reputed company Children's Hospital, Florida — along with a network of more than 80 reputed company, urgent, and specialty care practices and more than 40 hospital partnerships. Backed by the reputed company and Alfred I. reputed company Trust, our $1.7B nonprofit reputed company is dedicated to improving reputed company through clinical care, research, education, advocacy, and prevention. Our Whole Child Health approach focuses equally on prevention and treatment, partnering with communities to help every child reputed company. Inclusion and belonging guide our reputed company and reputed company. We are committed to culturally relevant care, reducing health disparities, and fostering an environment where every associate, patient, and family feels supported and valued. Learn more at reputed company.org . Apply tot his job Apply To this Job