Tracy Franklin Parker

About Tracy Franklin Parker

Multi-faceted professional with extensive experience in pharmaceutical CROs and CDOs. Acting SME for Medidata CTMS and eTMF at the most recent company. Skilled in training teams in Medidata CTMS, Cloud Admin, and Medidata eTMF, with a strong foundation in Adobe Acrobat, Microsoft Office Suite, SharePoint, and 21 CFR 11 regulatory guidelines. Knowledgeable in MedDRA® medical coding and EDMS. Has contributed to 300+ studies as a document coordinator, regulatory specialist, and clinical trial administrator, leading and mentoring teams to ensure operational excellence.Regulatory Document Coordinator | Sr. CTAEmail: t••••••••@icloud.comSKILLS:Medidata CTMS | Medidata eTMF | Medidata Cloud Admin | Training & Demonstrations | Project Management | SOPs / Training Modules Creation | Trial Master File (TMF/eTMF)| MedDRA® Medical Coding | SharePoint | Adobe Acrobat | Microsoft Office Suite | FDA/ICH/CDER/CBER/GCP/21CFR 11 and Regulatory guidelines | GCP Certified | Debenu & Autobookmark | Quality Control | Research | EDMSContact me at: t••••••••@icloud.com for any Regulatory or Sr. CTA opportunities.

Experience

1. Clinical Trial Associate

   ImmunityBio, Inc.

   Nov 2025 — Present

Skills

• Quality Assurance
• Clinical Data Management
• Public Speaking
• Biotechnology
• Management
• Clinical
• Quality Control
• Gmp
• Validation
• Glp
• Data Entry
• Clinical Research
• Regulatory Affairs
• Lifesciences
• Healthcare
• Oncology
• Project Management
• Microsoft Office
• Training
• CRO
• Medical Writing
• Biostatistics
• Pharmaceutical Industry
• Sop
• Fda
• Microsoft Excel
• Powerpoint
• Lims
• Excel
• Gcp
• Data Management
• Adobe Acrobat
• Ich-Gcp
• Process Improvement
• Regulatory Submissions
• Microsoft Word
• Software Documentation
• Edc
• Regulatory Requirements
• Visio