Research Regulatory Specialist

Research Regulatory Specialist Research Site - 4.0 Hialeah, FL Job Details Full-time $18 - $20 an hour 7 hours ago Benefits 401(k) Flexible schedule Qualifications Bilingual Teamwork Team leadership HIPAA Filing ICH guidelines Supervising experience Data management Attention to detail Full Job Description We are seeking an experienced, highly motivated, and detail-oriented Clinical Research Regulatory Specialist to join our growing clinical research team. In this critical role, you will oversee regulatory operations for clinical trials, ensuring compliance with applicable federal regulations, international guidelines, and institutional standards. Your expertise will be instrumental in supporting the successful initiation, management, and completion of clinical research studies while maintaining the highest standards of quality, ethics, and patient safety. This position offers an exciting opportunity to contribute to cutting-edge clinical development programs within a collaborative, innovative, and mission-driven environment dedicated to advancing medical science and improving patient outcomes. Key Responsibilities Prepare, review, and submit regulatory documentation for clinical trial applications, amendments, continuing reviews, annual reports, and study closeout activities in accordance with FDA regulations, ICH-GCP guidelines, and institutional requirements. Ensure ongoing compliance with all applicable regulatory requirements, including FDA regulations, HIPAA, Good Clinical Practice (GCP) standards, and other relevant federal, state, and local regulations. Monitor active clinical studies for regulatory compliance through routine audits, documentation reviews, and quality assurance activities. Serve as a key liaison between investigators, sponsors, CROs, IRBs, and regulatory agencies to facilitate timely approvals and maintain effective communication throughout the study lifecycle. Review and maintain regulatory files, essential study documents, and trial master files (TMFs) to ensure accuracy, completeness, and audit readiness. Collaborate with cross-functional teams to support study startup, maintenance, and closeout activities while ensuring adherence to established timelines and regulatory requirements. Provide guidance and training to research personnel on regulatory compliance, GCP principles, protocol requirements, documentation standards, and best practices. Maintain current knowledge of evolving regulatory requirements, industry trends, and best practices affecting clinical research and clinical trial management. Qualifications Minimum of 1 year of experience in clinical research, regulatory affairs, or a related healthcare environment, including demonstrated supervisory or leadership experience.

MUST BE BILINGUAL

Strong knowledge of clinical trial operations, protocol review, study conduct, and regulatory submission processes. Comprehensive understanding of FDA regulations, ICH-GCP guidelines, HIPAA requirements, and human subject protection standards. Experience reviewing and interpreting clinical documentation, regulatory records, and study-related data. Familiarity with clinical laboratory procedures, specimen collection processes, and patient assessment activities. Working knowledge of database systems and clinical research data standards. Exceptional organizational, analytical, and problem-solving skills with meticulous attention to detail. Excellent written and verbal communication skills, with the ability to collaborate effectively across multidisciplinary teams. Professional certifications such as ACRP-CP, CCRP, CCRC, CIP, or current GCP certification are strongly preferred. Why Join Us? Join a dedicated team committed to advancing healthcare through excellence in clinical research and regulatory compliance. This role offers the opportunity to make a meaningful impact by supporting innovative clinical studies that bring new therapies and treatments to patients. We value professionals who thrive in a fast-paced environment, embrace continuous learning, and are passionate about maintaining the highest standards of research integrity and regulatory excellence.

Pay:

$18.00 - $20.00 per hour

Benefits:

401(k) Flexible schedule

Work Location:

In person