Clinical Trials Regulatory Analyst I

University of Miami; Miami (FL); Remote; USD 60,000 - 75,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Tuition remission

Job summary

University of Miami is seeking a Regulatory Analyst I to prepare, submit, and maintain regulatory documentation for clinical trials from start-up through closure. You will support multiple trials and ensure compliance with SOPs and federal regulations.

The role involves preparing regulatory submissions, attending sponsor/CRO visits, and maintaining regulatory binders and documents with attention to accuracy and timelines.

Qualifications

• Bachelor's degree in a relevant field is required.
• Minimum of 1 year of regulatory/compliance experience in clinical/research settings.
• Knowledge of FDA, NIH and related regulatory requirements and guidelines.

Responsibilities

• Prepare and maintain regulatory documentation for clinical trials.
• Support multiple trials from start-up through study closure.
• Attend sponsor/CRO site visits for regulatory matters.
• Maintain Trial Master File and regulatory binders for accuracy.
• Ensure compliance with SOPs and applicable regulations (FDA/NIH).
• Assist with regulatory submissions and communications with regulators.

Skills

Interpersonal skills

Communication

Data analysis

Regulatory knowledge

Microsoft Office

Cross-functional teamwork

1-year regulatory experience

Education

Bachelor's Degree in relevant field

Tools

Microsoft Office

Job description

University of Miami is seeking a Regulatory Analyst I to prepare, submit, and maintain regulatory documentation for clinical trials from start-up through closure. You will support multiple trials and ensure compliance with SOPs and federal regulations.

The role involves preparing regulatory submissions, attending sponsor/CRO visits, and maintaining regulatory binders and documents with attention to accuracy and timelines.