Regulatory Assistant

Job Description Job Description The Regulatory Affairs Specialist Assistant supports the regulatory operations of the clinical research site by ensuring timely, accurate, and compliant preparation, submission, and maintenance of regulatory documentation. This role assists in maintaining adherence to ICH-GCP guidelines, FDA regulations, IRB requirements, and sponsor protocols, while contributing to audit readiness and overall site quality. Key Responsibilities: Assist in the preparation, review, and organization of regulatory documents (e.g., 1572s, CVs, medical licenses, training records) Maintain and update electronic regulatory systems (eReg) and ensure completeness of regulatory binders Track document expirations and ensure timely updates (licenses, GCP training, certifications) Assist in ensuring site compliance with FDA, ICH-GCP, and sponsor requirements Support internal audits, sponsor audits, and regulatory inspections by preparing and organizing documentation Participate in quality control (QC) checks of regulatory files Qualifications Education Associate’s or Bachelor’s degree in Life Sciences, Healthcare Administration, or related field preferred Experience 0–2 years of experience in clinical research or regulatory environment preferred Knowledge & Skills Basic understanding of ICH-GCP, FDA regulations, and clinical trial processes Strong organizational and documentation skills High attention to detail and accuracy Ability to manage multiple tasks and deadlines in a fast-paced environment Proficiency in Microsoft Office (Excel, Word) and electronic systems (eReg preferred) Company Description Sweet Hope Research Specialty, Inc. (dba Neoclinical Research) is a fast-growing, multi-specialty clinical research site located on a hospital campus in Miami Lakes, FL. We conduct Phase I–IV clinical trials across a wide range of therapeutic areas and are known for rapid study start-up, high enrollment, and strong sponsor relationships. We are seeking a detail-oriented and highly organized Regulatory Specialist Assistant to join our team and support regulatory operations across multiple active studies. Company Description Sweet Hope Research Specialty, Inc. (dba Neoclinical Research) is a fast-growing, multi-specialty clinical research site located on a hospital campus in Miami Lakes, FL. We conduct Phase I–IV clinical trials across a wide range of therapeutic areas and are known for rapid study start-up, high enrollment, and strong sponsor relationships.\r\n\r\nWe are seeking a detail-oriented and highly organized Regulatory Specialist Assistant to join our team and support regulatory operations across multiple active studies.