Lead Clinical Research Associate

About the role

The client, an Australian‑owned boutique CRO, is seeking an experienced Lead Clinical Research Associate to manage investigator and site selection, oversee full site lifecycle, and ensure compliance with regulatory standards across therapeutic areas.

Key responsibilities

• Identify, qualify, and select investigators and trial sites, conducting feasibility assessments.
• Oversee pre‑study, initiation, monitoring, and close‑out activities to optimise site performance.
• Conduct monitoring visits, perform source data verification and prepare monitoring reports.
• Maintain the Trial Master File and ensure timely, accurate documentation.
• Train investigators and site staff on protocol, GCP and regulatory requirements.
• Support ethics and regulatory submissions and manage site start‑up activities.

Required profile

• 7‑10+ years experience as a CRA or in a closely related clinical trial monitoring role.
• Tertiary qualification in science, health, nursing or related field with a current GCP certificate.
• Strong attention to detail, data‑integrity focus and ability to manage competing priorities.
• Excellent communication, planning and organisational skills, able to work independently and escalate issues.

Required skills

• Clinical monitoring and site management expertise.
• In‑depth knowledge of ICH‑GCP, TGA, NHMRC and Medicines Australia guidelines.
• Source data verification (SDV) and Trial Master File (TMF) maintenance.
• Investigator and site staff training on protocol and regulatory compliance.