Study Startup Specialist I

PSI CRO

4d•Onsite

About The Position

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. 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.

Requirements

College/University degree or an equivalent combination of education, training and experience
At least 1 year industry experience in clinical research and/or a minimum 1 year of Study Startup experience
Communication and organizational skills
Ability to negotiate and build relationships at all levels

Responsibilities

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.