Study Startup Specialist I - Remote

Overview

As a Study Startup Specialist I at PSI, you will be involved in the study startup processes in the US, providing operational support to project teams to ensure smooth and timely project initiation.

In Short

• Supports all processes critical for site activation.
• Supports Feasibility department with feasibility research and site identification process.
• Maintains project-specific tracking systems and electronic Trial Master File (eTMF).
• Provides administrative support with site agreement and budgets.
• Assists with site documents collection for IRB/IEC submission.
• Provides progress updates to all concerned functions.
• Identifies project-specific issues and escalates as needed.
• Supports preparation of study dossiers and IP-RED packages.
• Ensures exchange of information with investigational sites and vendors.
• May assist in document collection for audits.

Requirements

• College/University degree or equivalent experience.
• At least 1 year industry experience in clinical research.
• Minimum 1 year of Study Startup experience.
• Strong communication and organizational skills.
• Ability to negotiate and build relationships.

Benefits

• Focus on professional development and success.