Clinical Trials Assistant

IQVIA Inc; Sydney; On-site; AUD 55,000 - 75,000; Full time

Job summary

IQVIA is seeking an entry-level Administrative Support role to assist the Clinical Research Associates (CRAs) and RSU team with maintaining trial master files and regulatory documentation. The role involves handling, filing, and archiving study documents and supporting timely project delivery.

Responsibilities include assisting with study file reviews, clinical supplies tracking, data flow, and acting as a central communications contact. Some on-site support may be required after training.

Qualifications

• Minimum 2 years administrative support experience in clinical trials.
• Proficient with MS Word, Excel and PowerPoint; strong written/verbal English.
• Knowledge of GCP/ICH guidelines as provided in company training.

Responsibilities

• Assist CRAs and RSU with updating TMF and related documents.
• Handle, file and archive clinical documents per SOPs.
• Support study file reviews for completeness.
• Coordinate Clinical Trial Supplies and tracking information.
• Track and manage CRFs, queries and data flow.
• Act as central contact for project communications and documentation.
• May accompany CRAs on site visits after training.

Skills

Written English

Communication skills

Time management

Organizational skills

Relationship building

Education

High School Diploma or equivalent

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.