Regulatory Coordinator

Nemours Children’s 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.

About the role

The Regulatory Coordinator will manage regulatory processes from study initiation through close-out, ensuring all research activities comply 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. 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.

Responsibilities

• Manage day-to-day regulatory operations and workload of the 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 the team, including technology solutions; identify opportunities for expanding solutions to study teams.
• Coordinate with appropriate departments 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

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

About Us

Nemours Children's Health is an internationally recognized pediatric health system serving more than 1.7 million patient encounters each year. We deliver care across six states through two freestanding children’s hospitals — Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida — along with a network of more than 80 primary, urgent, and specialty care practices and more than 40 hospital partnerships. Backed by the Nemours Foundation and Alfred I. duPont Trust, our $1.7B nonprofit system is dedicated to improving children's health 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 thrive. Inclusion and belonging guide our strategy and growth. We are committed to culturally relevant care, reducing health disparities, and fostering an environment where every associate, patient, and family feels supported and valued.