Marie N.
- Role
- Senior Clinical Research Associate Iii at IQVIA
- Location
- Chicago, IL, US
- LinkedIn followers
- 500 followers
About Marie N.
IQVIA entrusted me with the Senior Clinical Research Associate role, where I…
Experience
Senior Clinical Research Associate Iii
May 2022 — Present
Oversee site activities, ensuring protocol adherence, regulatory compliance, and accurate data reporting. Conduct monitoring visits, ensuring adherence to GCP, ICH guidelines, and project scope. Collaborate with sites, strategize, and track tailored subject recruitment plans. Administer protocol training, manage communication, and maintain study integrity. Manage studies, overseeing regulatory submissions, enrollment, data resolution, and finances. Mentor clinical staff, providing support and training, and contributing to project execution. Specialize in monitoring Phase 1 Oncology Studies, and developing site-specific recruitment plans.
Skills
- Project Management
- Phase Iii
- Inform Gtm
- Siv
- Ctms
- Good Clinical Practice (Gcp)
- Microsoft Office
- Regulatory Compliance
- Standard Operating Procedure (Sop)
- Informed Consent
- Clinical Site Monitoring
- Fda Regulations
- Good Laboratory Practice (Glp)
- Phase Ii
- Business Development
- Field Monitoring
- Medical Devices
- Electronic Data Capture (Edc)
- Sae
- Imv
- Ecrf
- Ich
- Microsoft Excel
- Medidata
- Employee Training
- Gmp
- Clinical Research
- Regulatory Audits
- Clinical Trial Management System (Ctms)
- Protocol
- Phase Iv
- Fda
- Cov
- Clinical Trial Analysis
- Phase Ii Trials
- Oncology
- Microsoft Powerpoint
- Respiratory
- Source Data Verification
- Cardiology
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