Senior Study Startup Specialist

Summary

Join PSI, a leading Contract Research Organization, and contribute to the successful startup of clinical research studies. Coordinate study startup activities, lead feasibility research and site identification, and negotiate site agreements and budgets. Manage site document collection for IRB/IEC submissions, review study translations, and identify and escalate project issues. Prepare and submit study dossiers, ensure quality of IP-RED packages, and manage the distribution of clinical study supplies. Develop site-specific timelines and projections, provide training and support to operational staff, and support audit preparation. Finally, contribute to post-startup summaries of operational challenges and best practices.

Requirements

• University/college degree, or an equivalent combination of education, training, and experience
• At least 4 years’ experience in clinical research
• At least 3 years of full-scope Study Startup experience

Responsibilities

• Coordinate study startup activities with the local project team and supports all processes critical for site activation
• In the absence of stand-alone feasibility function, leads activities in feasibility research and site identification process
• Facilitates site agreement and/or budget negotiations with sites to ensure alignment to the site activation plan
• Leads site document collection for IRB/IEC submission and/or IP-RED process
• Reviews study-specific translations
• Identifies project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country
• Under supervision prepares and submits the study dossiers to investigators/institutions, competent authorities, IRBs/IECs
• Ensures quality of IP-REDs packages
• Ensures initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites
• Develops site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervision
• Provides startup-related training and methodological support to operational staff within the country/region
• Provides on-the-job coaching of department staff
• Supports preparation for audits on a country /regional level
• Upon completion of the project startup phase, supports the preparation of a summary on operational challenges, best practices and lessons learned, and reports to Study Startup management and other functions concerned

Benefits

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