Regulatory Analyst 1

University of Miami

Full-Time Regulatory Analyst I at University of Miami preparing regulatory documentation for clinical trials and providing support for compliance. Assisting in numerous aspects of regulatory processes for clinical research.

Posted 7/15/2026full-timeMiami • Florida • 🇺🇸 United StatesJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory documentation for clinical trials, ensuring compliance with federal, state, and local regulations while maintaining effective communication and interpersonal relationships with diverse stakeholders.

Highest-signal resume keywords

Regulatory Documentation ManagementClinical Trial ComplianceInterpersonal CommunicationData Collection and AnalysisMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationClinical Trial ProcessesData AnalysisProtocol ReviewSOP Compliance

Soft Skills

Effective CommunicationInterpersonal Relationship Building

Industry Keywords

FDA RegulationsNIH RegulationsClinical ResearchRegulatory SupportStudy Submissions

About the role

Key responsibilities & impact

Prepares, submits, and ensures proper maintenance of regulatory documentation for clinical trials from study start-up through study closure.
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.
Job duties will include, but not be limited to: Attend SDG Meetings to provide regulatory updates and guidance.
Build and maintain a working relationship with regulatory staff and provide guidance to Regulatory Specialist (RS).
Review protocol package for completion after PRC approval has been granted to guarantee the following documents are included: Protocol Document, Consent Form(s), IND Approval or Exemption Letter, Investigator’s Brochure, Draft Budget, CTA, Patient documents (if applicable), Recruitment materials (if applicable), External DSMB charter (if applicable).
Assist the Sr. Regulatory Analyst (RA) in the aspects of regulatory related issues.
Ensure compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and applicable regulations for the reporting of events to regulatory agencies.
Provide regulatory support for new and ongoing research studies. Includes but not limited to correspondence with institutional and federal regulators, study file documentation creation and maintenance.

Requirements

What you’ll need

Bachelor's Degree in relevant field
Minimum one (1) year of relevant experience in fields such as compliance, research, and/or medical/clinical.
Ability to maintain effective interpersonal relationships.
Ability to communicate effectively in both oral and written form.
Skill in collecting, organizing, and analyzing data.
Proficiency in computer software (i.e., Microsoft Office)
Ability to establish and maintain effective working relationships with diverse set of internal/external cross functional co-workers, managers, and clients.
Knowledge of processes associated with clinical trials.
Knowledge of applicable federal, state, and local rules and regulations.

Benefits

Comp & perks

medical
dental
tuition remission