Clinical Research Regulatory Specialist

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, SC, TX, VA, and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Regulatory Specialist is responsible for regulatory compliance and documentation, quality control, as well as organizational training related to GCP and SOP compliance. The RC maintains communication with the IRB and reviews on-site files, folders, binders, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides training and/or initiates corrective action as required. Ensures that essential documents are organized, up to date, and in compliance with ICH/GCP guidelines and federal regulations. Assists site-focused reviews, and quality improvement activities. Key Responsibilities Essential Job Duties: Maintains regulatory documents/binders in an organized and systematic fashion to facilitate the monitoring and auditing of research studies throughout the life of the studies. Keeps documents organized and ready for audit and ready for regulatory filings when required; Follows the organization’s SOPs and provides guidance with staff comprehension and compliance with the SOPs; Facilitates communication with the IRB and/