What are the responsibilities and job description for the Regulatory Coordinator position at Las Mercedes Medical Research?
Company Description Las Mercedes Medical Research is a clinical research organization dedicated to advancing medical knowledge and improving patient outcomes through high-quality clinical studies. The company focuses on conducting compliant, ethical, and well-structured research in collaboration with sponsors, investigators, and healthcare professionals. Based in South Florida, Las Mercedes Medical Research serves diverse patient populations and therapeutic areas. The team emphasizes accuracy, regulatory adherence, and patient safety in every aspect of its work. Joining the organization offers the opportunity to contribute to meaningful research that can impact future standards of care.
Role Description The Regulatory Coordinator is a full-time, on-site role based in Hialeah, FL. This role is responsible for preparing, submitting, and maintaining regulatory documents for clinical research studies, including IRB submissions, study start-up packages, protocol amendments, and ongoing reporting. The Regulatory Coordinator will track study approvals, maintain regulatory binders and electronic files, and ensure all documents remain current and compliant with applicable regulations and institutional requirements. Daily responsibilities include coordinating with investigators, study coordinators, sponsors, and IRBs, monitoring regulatory timelines, and promptly responding to regulatory queries or deficiencies. The role also involves supporting audits and inspections, assisting with the development and updating of standard operating procedures (SOPs), and helping train staff on regulatory documentation practices.
Qualifications
- Strong regulatory documentation skills, including preparation, organization, and maintenance of study files and regulatory binders.
- Knowledge of regulatory compliance and regulatory requirements related to clinical research (e.g., FDA, ICH-GCP, IRB requirements).
- Experience with regulatory submissions and regulatory affairs activities for clinical trials, including IRB submissions, amendments, and continuing reviews.
- Excellent attention to detail, time management, and organizational skills, with the ability to manage multiple studies and deadlines.
- Effective written and verbal communication skills for interacting with investigators, sponsors, IRBs, and internal teams.
- Proficiency with standard office software and electronic document management systems.
- Previous experience in clinical research, regulatory coordination, or IRB coordination is preferred but not mandatory.
- Ability to work on-site in Hialeah, FL, and collaborate in a diverse, cross-functional team environment.