Clinical Regulatory Specialist

Cignus Solutions LLC has openings for the position "Clinical Regulatory Specialist" with Master's degree in Any Analytical Science, Research Management or related in reviewing regulatory documents, including study materials and IRB binders, to ensure compliance with FDA guidelines and standard operating procedures. Apply project management and risk assessment skills to streamline submission planning, improve process efficiency, and meet key deadlines. Involve collaborating with the Principal Investigator to secure timely IRB approvals and regulatory filings. Stay current on regulatory changes, contributing to the development of SOPs for enhanced compliance. Tracking on CTMS and review of clinical study reports, research collaborations, and third-party studies. Managing document processing, including uploading final Study Reports to NDMS, PDF rendition, and Novstyle formatting. Ensure clinical trial registration SOPs are aligned with FDA and EMA guidelines and manage the documentation process, including final report uploads and formatting. Work location is Vernon Hills,IL with required travel and work from various unanticipated client worksites throughout the USA.Please mail resumes to 175 E Hawthorn Parkway, Suite # 401, Vernon Hills, IL-60061 (or) e-mail: