Clinical Research Regulatory Coordinator

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Cardiovascular Associates of America - CVAUSA

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51 - 200 employees

Founded 2021

Headquartered in Orlando, Cardiovascular Associates of America aims to bring the best cardiovascular physicians in one network with the common mission of saving lives, reducing costs, and improving patient care through clinical innovation. Through CVAUSA’s physician-centered practice management model, physicians drive clinical care and their practice culture, while benefiting from the business expertise and shared resources available through CVAUSA.

📋 Description

• 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

🎯 Requirements

• 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.

🏖️ Benefits

• None specified