- Collection, review, processing and tracking of regulatory and investigator documents to support Investigator Package submissions and revisions (e.g. amendments), Ensure ongoing and timely updates of documents and systems
- Site contract and budget negotiation
- Prepare submissions to IRB/IEC
- Collect and track regulatory and investigator documents required for effective and compliant site activation
- Ensure Start-up and Maintenance activities are on track and support study deliverables to include providing accurate projections/timelines to study sites, proactive site management, and active participation in team meetings
- Ensure high quality site documents are filed in TMF according to study plans
-B.A./B.S. (Life Science preferred) or equivalent healthcare experience
-Minimum 1-2 years in Clinical Research or relevant healthcare experience
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
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