Description
The Clinical Trials Regulatory Submissions Specialist serves as the primary contact for investigative sites during study maintenance and, when assigned, startup activities. The role collects and reviews investigator and regulatory documents, prepares and submits IRB, IEC, third-party, and regulatory authority submissions, coordinates with internal and external vendors, maintains study documentation and tracking systems, and escalates study issues. The position requires a university or college degree or related allied-health certification, and 0–2+ years of experience or an equivalent combination of education and experience; knowledge of ICH, RA, IRB/IEC, and the clinical trial process is also required.
