Regulatory Analyst 1 – Clinical Research

About the role

The University of Miami/UHealth Cancer Center is seeking a full‑time Regulatory Analyst 1 to support clinical research compliance. The analyst will conduct on‑site audits, review consolidated records, and help design and test treatment matrices to identify potential cancer cases from claims data.

Key responsibilities

• Analyze regulatory requirements, identify conflicts, and ensure compliance with federal regulations and university policies.
• Oversee accurate, timely processing, tracking, and filing of federally mandated submissions.
• Assist in drafting and presenting compliance programs to investigators and research staff.
• Review investigator submissions for content and provide feedback.
• Prepare and send decision correspondence and information requests.
• Maintain accurate databases, generate letters, and develop templates.
• Create files, mail notices, and safeguard university assets.
• Support the Clinical Research Services division in protocol development, IND submissions, budgeting, contracts, and safety reporting.

Required profile

• Bachelor’s degree in a relevant field.
• Minimum of 1 year of relevant experience.
• Strong attention to detail and ability to follow instructions.
• Effective oral and written communication skills.
• Professional composure in stressful situations and ability to maintain interpersonal relationships.

Required skills

What we offer

• Opportunity to work within a leading cancer research center.
• Remote work option available.
• Access to centralized research support services.