Regulatory Coordinator

Nemours Childrens Health is seeking a highly organized and detail-oriented Regulatory Coordinator to support the Nemours NCI Community Oncology Research Program (NCORP). This role is integral to the successful start-up activation and ongoing maintenance of pediatric oncology clinical research studies across the Nemours enterprise.

The Regulatory Coordinator will be responsible for managing regulatory processes from study initiation through close-out ensuring all research activities are conducted in compliance with federal regulations NCI/NCORP requirements and Nemours policies. This includes preparation and submission of regulatory documents management of the electronic regulatory binder (eReg) system maintenance of essential study records and coordination with investigators sponsors and internal teams.
Working in a fast-paced collaborative environment this individual will play a key role in supporting high-quality audit-ready research operations that advance innovative pediatric cancer care and improve outcomes for patients and families.

This is a Remote position. Applicants must reside in one of the following states: Alabama Colorado Delaware the District of Columbia Florida Georgia Illinois Maryland Missouri New Jersey New York North Carolina Ohio Pennsylvania South Carolina Tennessee Texas and Virginia.

Essential Functions

• Manage day-to-day regulatory operations and workload of regulatory team plan resource needs and strategize growth.
• Verification of NCORP protocols within Nemours CTMS
• Provide regulatory support for research programs and oversee maintenance of all required regulatory documents.
• Provide regulatory start-up support for research teams for all types of clinical trials.
• Partner with study teams to provide ad hoc regulatory management for ongoing clinical trials.
• Oversee timely regulatory submissions to meet project timelines.
• Oversee the electronic regulatory binder (eReg) system ensuring accurate complete and audit-ready documentation in alignment with GCP ALCOA-C principles and institutional requirements.
• Establish and maintain standardized processes for document collection version control review approval and filing within the eReg system.
• Ensure timely upload QC review and lifecycle management of essential documents (e.g. protocols investigator brochures IRB approvals safety reports delegation logs) within the eReg platform.
• Identify program improvement opportunities and lead improvement efforts within team including technology solutions; identify opportunities for expanding solutions to study teams.
• Coordinate with appropriate department to address regulatory-related quality and compliance matters.
• Assist with development of standard regulatory-related training requirements and provide ongoing education and training for investigators and research personnel including training on eReg system use and regulatory documentation standards.
• Work with Quality Assurance to perform internal audits and quality 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 Practice (GCP).
• Liaise with appropriate personnel departments and external entities on clinical trial regulatory operations.

Requirements

• Bachelors 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 (e.g. Florence eBinders Veeva eTMF or equivalent) strongly preferred
• Demonstrated understanding of GCP documentation standards and audit readiness expectations