Shannon G. Kelly

• Manage several studies for successful trial execution. Core responsibilities include scheduling monitoring visits, ensuring timely delivery of visit reports and letters, managing training creation and compliance, and conducting user access reviews to prevent breaches of confidentiality. Other duties include facilitating and summarizing meetings, resolving queries, sending mass email communications, and properly filing documents in the trial master file.

• Communicated directly with sites participating in the clinical trial to ensure complete and accurate data had been reported. Analyzed clinical documents to confirm compliance with GCP guidelines to verify sites were operating soundly to pass interim analyses and quality audits.

• Supported study teams by maintaining and creating documents, provided access to essential management systems, participated in meetings, provided daily reports, and communicated with site staff to guarantee their needs were met.

• Assisted commercial customers with the selection of products for their respective projects. This also entailed making customer accommodations, and processing shipments and returns.

• Conducted intake assessments and updated files for families living below the poverty line, documented clothing and household necessities, overcame language barriers, led and educated volunteer groups on poverty levels in the U.S.

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