Clinical Trial Assistant

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

Job Overview

Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions

• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications

• High School Diploma or equivalent
• 3 years administrative support experience.
• Equivalent combination of education, training and experience.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English language.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.