Regulatory Coordinator-Research

7 days ago

Jacksonville, Florida, United States Nemours Children's Health Full time
Job Summary

Nemours Children's Health is seeking a highly skilled Regulatory Coordinator-Research to oversee the day-to-day regulatory management of all types of clinical research protocols. This role will manage all aspects of study start-up, modification submissions, continuous reporting, and study close-out to the Institutional Review Board (IRB) and any relevant regulatory agencies.

Key Responsibilities
  • Manage day-to-day regulatory operations and workload of regulatory team, plan resource needs and strategize growth.
  • 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.
  • Create and maintain position-related Standard Operating Procedures (SOPs) and ensure procedural compliance.
  • 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 the development of standard regulatory-related training requirements and with ongoing education and training for investigators and research personnel.
  • Work with Quality Assurance to perform internal audits and quality assurance reviews on regulatory files, as needed.
  • Write and edit clinical research protocol consent forms in accordance with federal regulations and guidelines and good clinical practice (GCP) guidelines.
  • Liaise with appropriate personnel, departments, and outside entities on clinical trial regulatory operations.
Requirements
  • Bachelor's degree in Clinical Health Science/Healthcare Administration.
  • At least 2 years of Clinical Research Experience preferred.

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