Research Regulatory Analyst - Office of Clinical Research

Tampa General Hospital • Tampa, FL

19h

About The Position

Under the supervision of the Research Regulatory Supervisor, the Regulatory Analyst prepares, submits, and maintains regulatory documentation for clinical research studies to ensure compliance with study protocols, institutional policies and procedures, applicable regulations, and Good Clinical Practice (GCP) guidelines. This position is responsible for maintaining documentation of research team qualifications and training, supporting regulatory submissions and version control, and entering and tracking regulatory activity in Clinical Trial Management Systems (CTMS) to ensure timely documentation and support appropriate financial chargeability. Responsible for performing all duties in accordance with the mission, vision, and values of Tampa General Hospital (TGH).

Requirements

• Associate's Degree: Business, Science or Health related field
• Good Clinical Practice (GCP) within 30 days of hire
• Minimum of one (1) year of experience in clinical research, healthcare compliance, IRB coordination, or related regulatory support
• An equivalent combination of education and years of experience or realized competencies.

Responsibilities

• Prepares, submits, and maintains regulatory documentation for clinical research studies
• Ensures compliance with study protocols, institutional policies and procedures, applicable regulations, and Good Clinical Practice (GCP) guidelines
• Maintains documentation of research team qualifications and training
• Supports regulatory submissions and version control
• Enters and tracks regulatory activity in Clinical Trial Management Systems (CTMS)
• Ensures timely documentation and support appropriate financial chargeability
• Performs all duties in accordance with the mission, vision, and values of Tampa General Hospital (TGH)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree