Study Startup Specialist II
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Full-time
Remote
6d ago
Location:
US
Company:
PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.
Summary:
The Study Startup Specialist II coordinates key activities for site activation and supports feasibility operations. Applicants need a college degree in Life Sciences and at least 2 years of study startup experience.
Requirements:
Experience: At least 2 years of full-scope Study Startup experience in the country/region
Job Description:
Job Description:
- Coordinates 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
