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Assist with operational tasks across all study phases, from start-up through
closeout, with a focus on early study planning, site setup, and regulatory
submissions.
? Coordinate and maintain effective communication with external CROs, core labs,
and other vendors.
? Support the preparation and submission of global clinical study applications
(including IRB/EC submissions, regulatory filings, and study notifications).
? Collect and organize documentation from study sites, CROs, and external
partners.
? Upload and manage clinical trial documents in the eTMF system or other
relevant repositories.
? Maintain and update clinical tracking tools (e.g., site activation status, enrollment
projections).
? Process study-related invoices and track payment status.
? Contribute to the writing, editing, and review of clinical documents such as
protocols, study plans, ICFs, monitoring plans, site manuals, and other study-
related materials.
? Lead or actively contribute to the setup of new studies, including feasibility
assessments, site qualification, and contract management.
? Study Monitoring & Oversight
? Monitor the progress of clinical studies, ensuring compliance with protocols,
timelines, and regulatory requirements.
? Serve as a study monitor (CRA) for selected sites, including conducting initiation,
monitoring, and close-out visits as needed (remote and onsite).
? Willingness to travel abroad for monitoring visits occasionally.