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Regulatory Coordinator

workfromhome • Posted 4 days ago
Remote Full Time Business and Financial Operations Occupations

To support the Nemours NCI Community Oncology Research Program, the full-time remote Regulatory Coordinator will manage regulatory processes for pediatric oncology clinical research studies, ensuring compliance with federal regulations and internal policies while overseeing documentation and coordination with various stakeholders. Key responsibilities Manage day-to-day regulatory operations and workload of the regulatory team, planning resource needs and strategizing growth Oversee timely regulatory submissions and maintenance of essential study records within the electronic regulatory binder system Coordinate with study teams to provide regulatory support for clinical trials and assist with the development of training for research personnel Required qualifications Bachelor's Degree in Clinical Health Science or Healthcare Administration One to three years of regulatory coordination experience Two years of clinical research experience preferred Experience with electronic regulatory binder systems strongly preferred Demonstrated understanding of GCP documentation standards and audit readiness expectations

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