Senior Clinical Trial Associate
A global biopharmaceutical corporation headquartered in New Jersey is seeking to hire a Senior Clinical Trial Associate for a 6-month contract.
The Senior Clinical Trial Associate will be responsible for: 1) provide operational input on development, management and maintenance of study plans and tools. 2) Monitoring visit report review. 3) Support Health Authority inspections and CQA audits. 4) Provide proactive identification of potential risks and development/implementation of actions. 5) Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution. 6) Manage Trial Master File set-up, ongoing quality review, and final reconciliation. 7) Reconcile IP at study level in collaboration with IMSC.
Location: Summit, New Jersey
Compensation: $45-50 per hour
Duration: 6-month CONTRACT
- Education: Completed BA/BS in directly-relevant discipline or equivalent experience.
- Must have at least 4years' experience asCTA or experience working with a pharmaceutical corporation and were able to demonstrate the following:
- Review of monitoring visits reports
- ICF review
- CRO oversight or has worked on outsourced studies
- Writing study team minutes or running study team meetings
- Prior experience working with IVRS/EDC for data pulling/reports is preferred.
- Knowledge of ICH/GCP and regulatory guidelines/directives.
- Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
Sthree US is acting as an Employment Business in relation to this vacancy.