Regulatory Coordinator

This is a fully remote position, open to applicants in Alabama, +14 more states.

📋 Description

• Oversee daily regulatory operations and manage the workload of the regulatory team, while planning resource requirements and strategizing for growth.

• Validate NCORP protocols within Nemours CTMS.

• Offer regulatory support for research initiatives and supervise the upkeep of essential regulatory documents.

• Provide regulatory start-up assistance for research teams involved in clinical trials.

• Collaborate with study teams to deliver ad hoc regulatory management for ongoing clinical trials.

• Ensure timely regulatory submissions to adhere to project timelines.

• Manage the electronic regulatory binder (eReg) system, ensuring documentation is accurate, complete, and audit-ready, in compliance with GCP, ALCOA-C principles, and institutional standards.

• Develop and uphold standardized procedures for document collection, version control, review, approval, and filing within the eReg system.

• Guarantee prompt upload, quality control review, and lifecycle management of critical documents, including protocols, investigator brochures, IRB approvals, safety reports, and delegation logs.

• Identify opportunities for program enhancements and lead improvement initiatives, including technological solutions and the expansion of these solutions to study teams.

• Coordinate with various departments to resolve regulatory quality and compliance issues.

• Assist in developing regulatory training and educate staff on eReg usage and regulatory documentation standards.

• Collaborate with Quality Assurance on internal audits and quality assurance reviews of regulatory files and electronic regulatory binders.

• Compose and revise clinical research protocol consent forms in accordance with federal regulations, guidelines, and GCP.

• Serve as a liaison between personnel, departments, and external entities regarding clinical trial regulatory operations.

⛳️ Requirements

• Bachelor’s degree in Clinical Health Science or Healthcare Administration.

• One to three years of experience in regulatory coordination.

• Preferred two years of experience in clinical research.

• Strong preference for experience with electronic regulatory binder systems, such as Florence eBinders, Veeva eTMF, or similar.

• Proven understanding of GCP documentation standards and expectations for audit readiness.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional development and training.

• Supportive work environment fostering collaboration and innovation.