CRA SSU – 2+ Years Regulatory Experience – Sponsor Dedicated (Argentina)

About the role

Syneos Health is seeking a Clinical Research Associate (CRA) focused on Site Startup (SSU) to support sponsor‑dedicated projects in Argentina. The role involves managing regulatory submissions, site activation, and ensuring compliance with local and sponsor requirements.

Key responsibilities

• Prepare and submit Central and Local EC applications, regulatory authority submissions, and ongoing amendments.
• Track submission/approval timelines, monitor milestones in the SSU tracking system, and provide rationale for any delays.
• Support site selection, feasibility, and investigator contract/budget negotiations under supervision.
• Ensure all relevant documents are uploaded to the Trial Master File (TMF) according to SOPs.

Required profile

• Minimum 2 years of regulatory experience in clinical research.
• Ability to work remotely and coordinate with country start‑up advisors and project managers.
• Strong attention to detail and ability to follow SOPs and work instructions.

Required skills

• Regulatory submission preparation (EC, RA, safety notifications).
• Trial Master File (TMF) management.
• Site activation processes and feasibility support.
• Contract and budget negotiation support.