Clinical Trial Assistant

IQVIA LLC; Sydney; On-site; AUD 60,000 - 90,000; Full time

Job summary

IQVIA LLC in North Sydney, NSW, seeks a proactive Clinical Trial Assistant to support TMF delivery and site documentation. You will work with CRAs and RSU teams to maintain trial documents and ensure timely filing and archiving.

The role requires a high school diploma, 3 years of admin experience, and proficiency with Word, Excel and PowerPoint, plus clear English communication and strong organizational skills.

Qualifications

• High School Diploma or equivalent.
• 3 years administrative support experience.
• Proficient with MS Word, Excel and PowerPoint.
• Good written and verbal English communication.
• Strong time management and organizational skills.

Responsibilities

• Assist with TMF updates and maintenance of clinical documents.
• Support preparation, filing and archiving of study documents per SOPs.
• Review study files for completeness on a periodic basis.
• Assist with tracking of Clinial Trial Supplies and CRFs.
• Serve as central contact for project communications and documentation.

Skills

Administrative support

Communication

Time management

Education

High School Diploma or equivalent

3 years administrative support experience

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

## Clinical Trial AssistantApply: North Sydney, New South Wales, Australia: Full time: Posted Today: R1568661**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.comIQVIA 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.