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

About the role

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

Key responsibilities

• Prepare and submit Central and Local Ethics Committee (EC) applications, regulatory authority (RA) submissions, and ongoing amendments.
• Track project milestones in the SSU system, provide rationale for delays, and assist with contingency planning.
• Monitor financial aspects of the project, including contract hours and task allocations, and flag discrepancies.
• Ensure all required documents are uploaded to the Trial Master File (TMF) according to SOPs.
• Support site selection, feasibility assessments, and investigator contract and budget negotiations under supervision.

Required profile

• Minimum 2 years of regulatory experience in clinical research.
• Strong understanding of local Argentine regulatory requirements and ethics committee processes.
• Ability to work independently with oversight from the SSU Country Manager.
• Excellent organizational and time‑management skills.

Required skills

• Regulatory submission preparation and filing.
• Trial Master File (TMF) documentation management.
• Site activation and feasibility support.
• Contract and budget negotiation basics.