Clinical Trials Assistant

AUS IQVIA RDS Pty Ltd; North Sydney; On-site; AUD 65,000 - 78,000; Full time

Job summary

IQVIA Inc. is seeking an Administrative Support specialist to assist CRAs and RSU teams with clinical documentation, TMF maintenance, and regulatory compliance. You’ll handle filing, archiving, and distribution of trial materials within project timelines.

The role requires strong English communication, MS Office proficiency, and solid organizational skills. Prior clinical trials experience and knowledge of GCP/ICH are advantageous, with on-site responsibilities in North Sydney.

Qualifications

• Must have strong written and verbal communication in English.
• Proven time management and organizational abilities.
• Experience supporting clinical trials documentation and regulatory processes.

Responsibilities

• Assist CRAs and RSU with updating and maintaining TMF and trial docs.
• Support preparation, filing, distribution, and archiving of clinical docs per SOPs.
• Help track and review study files for completeness and regulatory compliance.

Skills

English communication

Time management

Organizational skills

Team collaboration

GCP/ICH awareness

Education

High School Diploma or equivalent with 2 years clinical trials admin support

Tools

MS Word

MS Excel

PowerPoint

Job description

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 Min 2 years administrative support experience in clinical trials.
• 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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.