Regulatory Coordinator

Company Overview

Las Mercedes Medical Research is a clinical research organization focused on generating reliable medical evidence and better health outcomes through carefully run clinical studies. The organization works closely with sponsors, investigators, and healthcare professionals to deliver ethical, compliant, and well-organized research. Operating from South Florida, the team supports a varied patient base and a range of therapeutic areas, with a strong emphasis on precision, patient safety, and adherence to regulations.

Role Summary

The Regulatory Coordinator position is a full-time, on-site opportunity in Hialeah, Florida. The main purpose of this role is to manage the preparation, submission, and ongoing upkeep of regulatory paperwork for clinical research projects. This includes IRB-related submissions, study initiation documentation, protocol change packages, and recurring reporting requirements.

Key Duties

In this position, you will monitor approval statuses, keep regulatory binders and digital records up to date, and make sure every document stays compliant with the relevant rules and institutional standards. You will work day to day with investigators, study coordinators, sponsors, and IRBs, follow regulatory deadlines, and address questions, corrections, or deficiencies without delay.

The role also includes helping with audit and inspection preparation, contributing to the creation and revision of SOPs, and assisting in training team members on best practices for regulatory records and documentation.

Qualifications

The ideal candidate should have strong experience handling regulatory paperwork, including organizing, preparing, and maintaining study files and binders. A solid understanding of compliance standards and clinical research regulations, such as FDA, ICH-GCP, and IRB requirements, is important. Experience with regulatory submissions and clinical-trial-related regulatory work, including IRB submissions, amendments, and continuing reviews, is preferred.

Strong organization, attention to detail, and time management are needed to balance multiple studies and deadlines. You should also be comfortable communicating clearly in writing and verbally with investigators, sponsors, IRBs, and internal teams. Familiarity with common office software and electronic document management tools is required. Prior work in clinical research, regulatory coordination, or IRB coordination is helpful, though not essential. The role requires the ability to work on-site in Hialeah, FL and contribute effectively in a collaborative, cross-functional environment.

Additional Information

This is a full-time, on-site position. No salary, openings, or start date details were provided in the source.