Study Startup Specialist I

Job Description

JOB DETAILS

REQUIREMENTS

• College/University degree or an equivalent combination of education, training and experience
• At least 1 year industry experience in clinical research and 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.

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