Regulatory Specialist - Clinical Research

Equity Medical is a growing clinical research organization committed to expanding access to innovative clinical trials and improving healthcare outcomes in the communities we serve. We are seeking an experienced and highly organized Regulatory Specialist to support clinical research activities at our Nashville, Tennessee site. This position requires someone who understands site-level regulatory operations, works well under competing deadlines, and can maintain accurate, audit‑ready study documentation. Key Responsibilities Prepare, collect, review, and maintain essential regulatory documents for clinical research studies. Manage regulatory binders and Investigator Site Files to ensure documentation remains complete, current, and audit‑ready. Coordinate and track submissions to Institutional Review Boards, sponsors, CROs, and other applicable parties. Support study start‑up activities, including regulatory document collection, submission preparation, and site activation requirements. Track study approvals, continuing reviews, amendments, safety reports, expirations, investigator credentials, licenses, CVs, and training records. Review regulatory documents for completeness, accuracy, and compliance before submission. Maintain delegation logs, financial disclosures, Form FDA 1572s, protocol signature pages, laboratory documentation, and other essential records. Coordinate closely with investigators, clinical research coordinators, site leadership, sponsors, CROs, and monitors. Prepare for and support monitoring visits, sponsor audits, and regulatory inspections. Identify missing or expiring documents and follow up promptly to resolve outstanding items. Maintain accurate information in applicable clinical trial management and electronic regulatory systems. Follow company SOPs, ICH‑GCP requirements, FDA regulations, sponsor requirements, and applicable federal and state standards. Perform additional regulatory and administrative responsibilities as assigned. Qualifications Bachelor’s degree in life sciences, healthcare, clinical research, or a related field preferred. At least two years of clinical research regulatory experience strongly preferred. Experience working at a clinical research site, site network, CRO, academic medical center, or similar environment. Working knowledge of ICH‑GCP, FDA regulations, essential clinical trial documents, and site‑level regulatory requirements. Experience supporting multiple clinical studies and managing competing deadlines. Strong attention to detail, organization, follow-through, and document‑management skills. Strong written and verbal communication skills. Proficiency with Microsoft Office or Google Workspace. Experience with CRIO, Florence eBinders, Veeva, or another CTMS or eRegulatory platform is preferred. Position Requirements This is a fully on‑site position in Nashville, Tennessee. Candidates must be able to work in person during established business hours. Remote and hybrid arrangements are not available for this role. Employment is contingent upon completion of applicable pre‑employment requirements. Why Join Equity Medical Join a rapidly growing clinical research organization. Support meaningful work that helps bring new therapies to patients. Work collaboratively with experienced clinical research professionals. Build your career in an environment focused on quality, accountability, and professional growth. Equity Medical, LLC is an equal opportunity employer. #J-18808-Ljbffr Equity Medical