Job Overview We are seeking a highly motivated and detail-oriented Regulatory Coordinator specializing in Clinical Research to join our dynamic team. In this pivotal role, you will oversee the regulatory aspects of clinical trials, ensuring compliance with industry standards and government regulations. Your expertise will facilitate smooth study operations, support clinical development processes, and uphold the highest standards of research integrity. This position offers an exciting opportunity to contribute to groundbreaking healthcare advancements while working in a collaborative, fast-paced environment committed to excellence. Responsibilities Manage and maintain regulatory documentation for clinical trials, including submission packages, ethics committee approvals, and regulatory agency filings. Review and verify clinical trial documentation for accuracy, completeness, and compliance with FDA regulations, ICH GCP guidelines, and other applicable standards. Coordinate with study teams to ensure timely submission of regulatory documents and monitor ongoing compliance throughout the trial lifecycle. Assist in preparing for audits and inspections by regulatory authorities, ensuring all documentation meets quality assurance standards.. Collaborate with project teams to ensure data collection aligns with GCP standards and EMR systems are correctly utilized for data management. Supervise junior staff or team members involved in regulatory activities, providing guidance on documentation review and compliance management. Requirements Proven supervising experience within a clinical research or healthcare setting. Strong knowledge of medical terminology, clinical research methods, and healthcare compliance standards such as HIPAA and FDA regulations. Experience reviewing clinical trial documentation, including protocols, informed consent forms, and case report forms. Proficiency in statistical software, Microsoft Office Suite (Word, Excel, PowerPoint), and data management tools aligned with research projects. Certification in ICH Good Clinical Practice (GCP) from a recognized issuer is preferred. Demonstrated understanding of clinical development phases and ethical guidelines governing research projects. Ability to manage multiple projects simultaneously while maintaining attention to detail and compliance standards. Excellent analysis skills combined with strong organizational abilities to support research project management effectively. Join us in advancing healthcare through meticulous research coordination! This paid position offers an engaging environment where your expertise directly impacts innovative clinical trials that improve patient outcomes worldwide. We value dedication, precision, and proactive collaboration—qualities that drive our mission forward every day.

Pay:

$23.00 - $30.00 per hour Expected hours: 40.0 per week

Benefits:

401(k) Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person