iCRA - Initiation Clinical Research Associate

Parexel • Remote (Argentina) • 2w ago

Key Responsibilities:

Manage and direct the strategy for study start-up, pre-Site Initiation Visit (SIV) tasks, and study activation.
Act as the direct point of contact with assigned sites.
Develop relationships with investigators and site staff.
Manage country-specific feasibility activities and/or site qualification. Handle essential regulatory documents and informed consent forms.
Prepare and submit applications to IRB/IEC and MoH/RA.
Develop and review plans for regulatory approval, site activation, and patient recruitment.
Resolve issues and escalate site-related matters.
Conduct on-site and remote visits.
Ensure compliance with ICH-GCP and applicable regulations.

Key Skills:

Requirements:

University degree in biological sciences, pharmacy, or health-related discipline (preferred).
Relevant previous work experience (preferred).
Good English skills.

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