Provide centralized regulatory support for the CVRS clinical research network
Support regulatory start-up, site activation, IRB management, regulatory maintenance, and quality review activities across multiple clinical research sites
Prepare and maintain regulatory documentation
Coordinate IRB submissions and amendments
Manage electronic regulatory files within REALTIME
Support study activation activities
Conduct regulatory quality reviews
Serve as a regulatory resource for research sites
Ensure compliance with sponsor requirements, IRB requirements, Good Clinical Practice (GCP), FDA regulations, and CVRS Standard Operating Procedures

Associate's Degree required
Bachelor's Degree in Life Sciences, Healthcare Administration, Public Health, or related field preferred
Minimum 2 years of clinical research regulatory experience required
Experience preparing IRB submissions, amendments, and continuing reviews required
Experience supporting study start-up and site activation activities preferred
Experience working in a multi-study or multi-site environment preferred
Experience using REALTIME CTMS and eRegulatory modules strongly preferred
Experience with central IRBs and local IRBs
Experience supporting sponsor and CRO interactions
Experience preparing studies for sponsor monitoring visits, audits, and inspections
Experience supporting remote research operations
Strong knowledge of ICH-GCP guidelines
Working knowledge of FDA regulations and human subject protection requirements
Exceptional attention to detail and document accuracy
Strong organizational and project management skills
Ability to manage multiple studies and competing deadlines
Excellent written and verbal communication skills
Ability to work independently in a remote environment
Proficiency with Microsoft Office applications and electronic regulatory systems.

Clinical Research Regulatory Coordinator

Key skills