Senior Clinical Trial Lead: End-to-End Coordination

Kanji Group; Sydney; On-site; AUD 90,000 - 120,000; Full time

Job summary

Key Health Medical Centre in Sydney CBD South seeks a Senior Clinical Trial Coordinator to lead the coordination and delivery of multiple clinical trials within our Clinical Research Unit. You will work with experienced clinicians, investigators and sponsors to ensure trials are conducted safely, efficiently and in line with GCP and regulatory requirements.

You will report to the Clinical Trial Manager, oversee day-to-day study delivery, provide guidance to team members, and help maintain high

Qualifications

• Experience coordinating multiple clinical trials within a medical centre, research site, hospital, CRO or similar environment.
• Strong understanding of ICH-GCP and clinical trial requirements.
• Experience with regulatory documentation and trial data systems (EDC/CTMS/eTMF).
• Experience coordinating study start-up activities and essential documentation.

Responsibilities

• Coordinate and deliver day-to-day activities across multiple clinical trials.
• Lead start-up activities including site initiation and feasibility.
• Manage study timelines, milestones, and site activities to meet protocols.
• Schedule participant visits and coordinate investigator and research nurse availability.
• Maintain TMF/eTMF and study documentation in an audit-ready state.
• Support monitoring visits, audits and regulatory inspections.
• Identify and address study issues, risks and protocol deviations.
• Coordinate participant recruitment, screening, enrolment and retention.
• Ensure regulatory submissions, amendments and safety reporting are managed.
• Build strong relationships with sponsors, CROs and study teams.

Skills

ICH-GCP

EDC/CTMS/eTMF

Stakeholder management

Regulatory compliance

Documentation accuracy

Site initiation & feasibility

GCP Certification

Education

Bachelor of Nursing

Science degree considered

Tools

EDC systems

CTMS systems

eTMF systems

Job description

Key Health Medical Centre in Sydney CBD South seeks a Senior Clinical Trial Coordinator to lead the coordination and delivery of multiple clinical trials within our Clinical Research Unit. You will work with experienced clinicians, investigators and sponsors to ensure trials are conducted safely, efficiently and in line with GCP and regulatory requirements.

You will report to the Clinical Trial Manager, oversee day-to-day study delivery, provide guidance to team members, and help maintain high