Remote Clinical Research Regulatory Specialist

Cardiovascular Associates of America; Brandon (FL); Hybrid; USD 52,000 - 75,000; Full time

Job summary

Cardiovascular Associates of America is seeking a Clinical Research Regulatory Coordinator for a hybrid role in Brandon, FL. The incumbent will manage regulatory documents, IRB submissions, and sponsor communications across multiple sites.

Responsibilities include coordinating start-up, site activation, and quality reviews, while maintaining REALTIME eRegulatory files and ensuring compliance with GCP and FDA regulations. Independent work in a remote environment is essential.

Qualifications

• 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.

Responsibilities

• Prepare and assemble study start-up regulatory packages.
• Coordinate collection of essential documents for site activation.
• Prepare sponsor-required regulatory submissions.
• Support feasibility, site qualification, and activation activities.
• Coordinate sponsor and CRO requests during study start-up.
• Track regulatory milestones and deliverables.
• Maintain study start-up trackers and timelines.
• Prepare and submit IRB applications and amendments.
• Maintain regulatory files in REALTIME and ensure version control.

Skills

Attention to detail

Organizational skills

Project management

Communication skills

Independent work in remote environment

Education

Associate's Degree

Bachelor's Degree preferred

Tools

REALTIME CTMS

Microsoft Office

eRegulatory systems

Job description

Cardiovascular Associates of America is seeking a Clinical Research Regulatory Coordinator for a hybrid role in Brandon, FL. The incumbent will manage regulatory documents, IRB submissions, and sponsor communications across multiple sites.

Responsibilities include coordinating start-up, site activation, and quality reviews, while maintaining REALTIME eRegulatory files and ensuring compliance with GCP and FDA regulations. Independent work in a remote environment is essential.