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University of Miami · 8 hours ago

Regulatory Analyst 1

Miami, FL

Full-time

Hybrid

Entry Level

1+ years exp

The University of Miami is a leading academic medical center providing innovative patient care and research. They are seeking a Regulatory Analyst 1 to conduct audits, analyze regulatory requirements, and support clinical trials by ensuring compliance with federal regulations and university policies.

Higher Education

Responsibilities

Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies

Oversees accurate and timely processing, tracking, and filing of federally mandated submissions

Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance

Provides support to investigators by reviewing submissions for content

Sends decision correspondence to appropriate parties, requesting information

Maintains accurate databases and generates letters

Develops and maintains templates, creates files, and mails notices

Adheres to University and unit-level policies and procedures and safeguards University assets

Facilitates the process of preparing required regulatory documentation for initial and subsequent study submissions to various boards, committees, industry, academic, and cooperative sponsors

Provides regulatory support for multiple clinical trials from study start-up through study closure

Generates and updates essential regulatory documents, accordingly, including the editing of consent forms appropriately based on required institutional language and/or study revisions

Attends site visits conducted by sponsor/Contract Research Organization (CRO) for matters concerning regulatory documents

Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adheres to university and department-level policies and procedures and safeguards University assets

Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and other applicable regulations