ICON Strategic Solutions · 1 day ago
Clinical Trial Associate
Wilmington, DE
Full-time
Hybrid
Entry Level
3+ years expICON Strategic Solutions is currently hiring for a client dedicated, hybrid-based Clinical Trial Associate. The role involves collecting, preparing, reviewing, and tracking documents for the application process and ensuring timely submission to relevant authorities throughout the study.
Hiring Manager
John Burgess
Responsibilities
Collects, assists in preparation, reviews and tracks documents for the application process
Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study
Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents
Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study
Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements
Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF 'Inspection Readiness'
Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF
Qualification
Required
Three days in the sponsors Wilmington, DE based office is required for this role
Collects, assists in preparation, reviews and tracks documents for the application process
Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study
Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents
Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study
Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements
Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF 'Inspection Readiness'
Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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