Take your career to the next level and be involved in study startup processes in the US. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time.
You will:
- 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) throughout study startup phase.
- Provides administrative support with site agreement and budgets.
- Assists with site documents collection for IRB/IEC submission and/or IP-RED process.
- Provides progress updates to all concerned functions.
- Identifies project-specific issues and escalates as outlined in the project specific Communication Plan.
- Supports preparation of study dossiers to sites and competent authorities.
- Supports preparation of IP-RED packages.
- Ensures exchange of information and documentation with investigational sites, off -site facilities and vendors throughout study startup phase.
- Additional responsibilities may include collecting documents in preparation for audits on a country-region level.