Clinical Research Regulatory Coordinator

Cardiovascular Associates of America - CVAUSA

Clinical Research Regulatory Coordinator providing centralized regulatory support for CVRS clinical research network. Handling IRB submissions, regulatory documentation, and quality reviews across multiple sites.

Posted 6/23/2026contractRemote • 🇺🇸 United StatesJuniorMid-LevelWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

None specified 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory documentationIRB submissionsregulatory maintenanceregulatory quality reviewsclinical research regulatory experiencestudy start-upsite activationICH-GCP guidelinesFDA regulationshuman subject protection

Soft Skills

attention to detaildocument accuracyorganizational skillsproject management skillsability to manage multiple studiescompeting deadlineswritten communication skillsverbal communication skillsindependent workremote work

Certifications

Associate's DegreeBachelor's Degree in Life SciencesBachelor's Degree in Healthcare AdministrationBachelor's Degree in Public Health