Regulatory Analyst

Regulatory Analyst 1 – University of Miami

Join to apply for the Regulatory Analyst 1 role at University of Miami
. This full‑time staff position is available for remote work.

Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please  to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.

The Regulatory Analyst 1 – UHealth conducts on‑site audits and reviews consolidated records, and designs, reviews, and tests the revised treatment matrix to identify potential cancers from claims data.

• 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.

This list of duties and responsibilities is not intended to be all‑inclusive and may be expanded to include other duties or responsibilities as necessary.

Education: Bachelor’s degree in a relevant field.

Experience: Minimum 1 year of relevant experience.

Knowledge, Skills and Attitudes:

• Skill in completing assignments accurately and with attention to detail.
• Ability to communicate effectively in both oral and written form.
• Ability to handle difficult and stressful situations with professional composure.
• Ability to maintain effective interpersonal relationships.
• Ability to understand and follow instructions.

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, including the editing of consent forms to meet institutional language and 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.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth is South Florida’s only university‑based health system, providing leading‑edge patient care powered by groundbreaking research and medical education at the Miller School of Medicine. As an academic medical center, we proudly serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub‑specialties, and we have more than one million patient encounters each year, earning worldwide recognition for outstanding teaching, research and patient care.

The University of Miami is an Equal Opportunity Employer – Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. for additional information.