Job Description

Our small pharmaceutical client is seeking a highly organized, detail‑driven Clinical Trial Associate to support critical activities across their Expanded Access Program (EAP), legacy trials, and inspection readiness initiatives. This role is ideal for someone who thrives in a fast‑paced environment, enjoys cross‑functional collaboration, and is motivated by work that directly supports patient access and regulatory success.

What You’ll Do

As a key member of our Clinical Operations team, you will:

Inspection Readiness & Quality Support

• Support mock inspection remediation activities, including eTMF cleanup, document review, and WEP task review.
• Review and QC the current EAP eTMF, summarizing status and outlining next steps.
• Partner closely with QA to support site preparation planning leading up to inspections.
• Support CAPA completion and remediation activities to ensure inspection readiness.
• Contribute to site inspection readiness efforts across multiple programs.

Study Coordination & Logistics

• Provide operational support for study coordination and logistics across EAP and legacy trials.
• Assist with all facets of preparation for EAP and legacy studies, including eTMF updates and GDP review.

Data Collection & Monitoring Support

• Support additional data collection efforts related to ongoing program needs.
• Play an integral role in EAP data collection and full monitoring activities.

What You Bring

We’re looking for someone who is:

• Highly organized with strong attention to detail
• Comfortable working with eTMF systems and documentation workflows
• Effective at collaborating with cross‑functional partners, especially QA
• Motivated by improving processes and supporting inspection readiness
• Eager to grow within Clinical Operations and contribute to meaningful patient‑focused work

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