Role Overview
Join a respected academic health system in Miami as a Regulatory Analyst 1, supporting the integrity and compliance of clinical research operations. This position plays a key role in maintaining regulatory standards across investigator-initiated, industry-sponsored, cooperative group, and emergency-use trials. You will work closely with research teams, institutional review boards, and compliance committees to ensure all regulatory requirements are met from study initiation through closure.
Key Responsibilities
- Evaluate regulatory guidelines and identify areas of non-compliance or procedural conflict
- Prepare, review, and submit regulatory documents to the Institutional Review Board (IRB), ensuring alignment with federal and institutional standards
- Develop and maintain regulatory binders—both electronic and physical—containing essential study documentation
- Standardize and revise informed consent forms and other study materials for regulatory approval
- Coordinate submission packages using data from internal review committees and sponsor requirements
- Support research staff by reviewing protocol submissions for completeness and accuracy
- Issue correspondence related to regulatory decisions and follow up on outstanding documentation
- Ensure all study personnel complete required training and that records are properly maintained in regulatory files
- Manage delegation of authority logs and verify team credentials in compliance with study protocols
- Maintain accurate records in institutional systems such as Velos and Complion
- Communicate effectively with sponsors, contract research organizations, and internal departments to support trial compliance
Qualifications
Candidates must hold a bachelor’s degree in a relevant field and have at least one year of experience in clinical research or regulatory affairs. Proficiency in Microsoft Office is required, along with familiarity with electronic regulatory systems. You should demonstrate strong organizational skills, attention to detail, and the ability to interpret federal regulations and institutional policies. Experience with IRB procedures and clinical trial protocols is essential. Strong written and verbal communication skills are necessary for effective collaboration with research teams and compliance entities.
Work Environment
This hybrid role is based in Miami, FL, with flexibility for remote work. You will be part of an institution dedicated to advancing medical knowledge and serving diverse communities across South Florida, Latin America, and the Caribbean. The organization values integrity, equity, and excellence in research and patient care.
Compensation and Benefits
This position offers a competitive salary and a comprehensive benefits package, including medical and dental coverage. Additional benefits include tuition remission and institutional support for professional development. As an Equal Opportunity Employer, the organization supports workplace diversity and inclusion in accordance with federal law.
