Study Startup Specialist II

Summary

Join PSI, a leading Contract Research Organization, and contribute to the successful startup of clinical studies. Coordinate crucial site activation activities, support the Feasibility department, and facilitate negotiations for site agreements and budgets. Collect necessary documents for IRB/IEC submissions and the IP-RED process, manage translations and reviews, and oversee the initial distribution of investigational products and supplies. Prepare and submit study dossiers to sites, competent authorities, and IRBs/IECs, and support study supplies distribution. PSI offers excellent working conditions, extensive training, a competitive salary and benefits package, and opportunities for personal and professional growth.

Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training and experience
• At least 2 years of full-scope Study Startup experience in the country/region
• Well-developed communication and organizational skills
• Ability to negotiate and build relationships at all levels

Responsibilities

• Coordinate study startup activities critical for site activation
• Supports Feasibility department
• Facilitates site agreement and/or budget negotiations
• Collects site documents for IRB/IEC submission and/or IP-RED process
• Coordinates translation and reviews
• Support initial distribution of Investigational Product(s) and clinical study supplies to sites
• Under supervision prepares and submits the study dossiers to sites, competent authorities, IRBs/IECs, Prepares IP-REDs packages
• Support study supplies distribution to sites

Benefits

• Excellent working conditions
• Extensive training and friendly team
• Competitive salary and benefits package
• Opportunities for personal and professional growth