Sr. Regulatory Analyst

University of Miami; Miami (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

The University of Miami is seeking a Full-Time Sr. Regulatory Analyst to enhance research operations at the UHealth Medical Campus. This role focuses on regulatory support, compliance management, and documentation for cancer-related studies, requiring three years of relevant experience and strong organizational skills. Competitive salaries and comprehensive benefits, including medical and tuition remission, are provided.

Benefits

Medical benefits

Dental benefits

Tuition remission

Qualifications

• At least three years of Regulatory Affairs experience in research or equivalent.
• CRP certification preferred.

Responsibilities

• Provide regulatory support for research studies.
• Obtain regulatory packets from investigators or CROs.
• Design and conduct training programs for research staff.
• Develop SOPs and address compliance issues.

Skills

Organizational skills

Communication skills

Knowledge of NCI guidelines

Ability to manage multiple tasks

Familiarity with medical terminology

Proficiency with Microsoft Office

Education

Relevant education or certifications

Job description

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Job Overview

The University of Miami / UHealth Department of SCCC has an exciting opportunity for a Full-Time Sr. Regulatory Analyst at the UHealth Medical Campus in Miami, FL. The role involves supporting the Population Sciences Research Operations Office of Regulatory Services / Behavioral and Community-Based Shared Research of the Sylvester Comprehensive Cancer Center with submissions to various review committees for cancer-related studies.

Primary Duties & Responsibilities

• Provide regulatory support for research studies, including communication with regulators and documentation management.
• Obtain initial regulatory packets from investigators or CROs.
• Design and conduct training programs for research staff.
• Develop SOPs and address research compliance issues.
• Verify credentials of study personnel and ensure documentation accuracy.
• Assist with protocol submissions and maintain study documentation.
• Coordinate communication and documentation with study teams and sponsors.
• Organize and store protocol files and correspondence.
• Prepare response letters for review committees.
• Support audit responses and attend regulatory meetings.
• Perform additional duties as assigned.

Required Qualifications

• At least three years of Regulatory Affairs experience in research or equivalent.
• CRP certification preferred; strong organizational and communication skills.
• Relevant education, certifications, or work experience considered.

Knowledge, Skills, and Abilities

• Knowledge of NCI guidelines, IRB policies, and industry regulations.
• Ability to manage multiple tasks in a fast-paced environment.
• Familiarity with medical terminology and research protocols.
• Proficiency with Microsoft Office.

Additional Information

The university offers competitive salaries and benefits, including medical, dental, and tuition remission. We are an Equal Opportunity Employer. Employment is full-time, staff position, with a pay grade of H9. The role is classified as Mid-Senior level in a full-time capacity within the Higher Education industry.

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