Clinical Trial Admin & Documentation Coordinator

IQVIA; Sydney; On-site; AUD 65,000 - 90,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services and healthcare insights. We are seeking an Administrative Support Associate in Sydney to assist with Trial Master File delivery and support the CRA and RSU teams, ensuring timely, compliant documentation.

You will help prepare, file and archive clinical documents, maintain tracking systems, and support study teams in meeting project timelines within a regulated environment.

Qualifications

• Minimum 3 years of administrative support experience.
• Microsoft Word, Excel and PowerPoint proficiency.
• Diploma or equivalent education required; equivalent combination of education, training and experience accepted.
• Good written and verbal English communication.
• Strong time management and organizational abilities.
• Ability to build and maintain effective working relationships.
• Familiarity with clinical research regulatory requirements (GCP/ICH) and protocol knowledge.

Responsibilities

• Assist CRAs and RSU with updating and maintaining TMF and related documents.
• Prepare, handle, distribute, file and archive clinical documents and reports per SOPs.
• Periodically review study files for completeness.
• Assist with Clinical Trial Supplies tracking and documentation.
• Track Case Report Forms and data flow; support project communications.
• May accompany CRAs on site visits for monitoring duties after training.

Skills

Administrative support

Written and verbal communication

Time management

Organizational skills

Relationship building

GCP/ICH regulatory awareness

Education

High School Diploma or equivalent

Tools

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is a leading global provider of clinical research services and healthcare insights. We are seeking an Administrative Support Associate in Sydney to assist with Trial Master File delivery and support the CRA and RSU teams, ensuring timely, compliant documentation.

You will help prepare, file and archive clinical documents, maintain tracking systems, and support study teams in meeting project timelines within a regulated environment.