Clinical Research Coordinator
Current• Successfully and consistently coordinated the collection, review, and processing of clinical trial documents to/from investigators for over 125 sites for multiple studies in adherence to the Alcon Standard Operating Procedures (SOPs), the study specific protocol reporting requirements, good clinical practices (GCP), the Federal Drug Administration (FDA) Code of Federal Regulations (CFR) including Title 21 CFR Part 11 and ICH guidelines. Consistently met or exceeded accuracy and study timeline deliverables of site documents throughout study life cycle by communicating effectively with investigator’s site staff, Clinical Site Management personnel, ensuring study documents were well organized, filed appropriately, current and available in the TMF to resolve queries and ensure inspection readiness. Consistently met or exceeded CTMS document tracking requirements, ensuring all information was correct, available for review and crosschecking against study site trial master file (TMF) for accuracy and audit readiness. Was involved in special project involving Latin American sites to include IRB submissions.
