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Regulatory Lead (Support)
US Clinical Site Network Tuesday, 23 June 2026Job Summary
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 applicable. This process applies to both paper & electronic files for each study site. Maintain the confidentiality of study protocol information & Protected Health Information (PHI). Create error-free written documents & reports (e.g., cover letters, notes to file, memoranda, etc.). Perform duties in a safe and prudent manner. Perform study-related duties in a timely and cost-effective manner while adhering to policies. The position is remote, thus applicants from all provinces can apply.Error!
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