Experience

CROMSOURCE - A ClinChoice Company

• Italy
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Clinical Research Associate

  • Feb 2020 - Present

  • Conduct investigative site file reconciliation, request new or updated essential and non-essential site-related documents, review them for content and consistency, and ensure compliance with local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.• Monitor clinical trials to ensure compliance with applicable local regulatory requirements and ICH guidelines, meeting sponsor and investigator obligations.• Visit sites to assess the qualifications of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, review data to ensure data accuracy, and terminate studies when necessary.• Perform billable work in accordance with company policies, procedures, and Standard Operating Procedures. Show less

• Clinical Research Associate I/II

  • Dec 2016 - Jan 2020

  • Perform source document review and verification as outlined in the monitoring plan, ensuring alignment between subjects' medical records in the electronic medical record (EMR) and supplemental documents with the study data in the Electronic Data Capture (EDC) system.• Assist the clinical operations team in preparing and presenting at investigator meetings to ensure that the study and related procedures are well understood by the clinical and investigational site staff.• Review, analyze, and interpret study data, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify trends in protocol deviations, and escalate them to the Clinical Trial Manager as needed.• Proactively schedule on-site visits to meet the company's expectations for the number of site visits. Track and update site visit details and escalate any issues to the Clinical Trial Manager as necessary. Show less

• Clinical Trial Assistant Intern

  • Sep 2015 - Nov 2016

  • Reviewed data entry in source documents and the Electronic Data Capture (EDC) system for completeness and accuracy, ensuring compliance with ALCOAC+ principles and study requirements.• Assisted study coordinators with the submission of essential documents for study start-up and Institutional Review Board (IRB) approval.• Screened potential study participants to ensure they met the study's inclusion and exclusion criteria for enrollment and obtained consent from eligible participants for study enrollment.• Maintained accurate logs of study participant screening and enrollment as directed by the study coordinator. Show less