Regulatory lead (support)

Job Overview Prepare, maintain, & provide oversight of research-related regulatory documents. Populate & coordinate the entire process for the initial submission of regulatory documents to the IRB, sponsors, & state/ federal regulatory offices, as necessary. Compile study information & submit initial, continuing, & final reports to the IRB and/or sponsor. Prepare applicable submission forms & submit updated documents, including but not limited to amendments, addenda, Investigator's Brochures, safety information, FDA Form 1572s, & informed consent documents. Accurately file & maintain required logs within the appropriate regulatory repositories. Assist with & manage the archiving of clinical trial documents & records. Prepare for monitoring visits and audits. Distribute, collect, process, & track Essential Site Regulatory Documents for ongoing studies, including the collection of updated investigators, pharmacists, & nursing CVs, licenses, GCP, IATA, & training certificates, as applicab...