Clinical Trial Assistant

IQVIA Argentina; Sydney; On-site; AUD 60,000 - 70,000; Full time

Job summary

IQVIA is seeking an Administrative Support Specialist to assist Clinical Research Associates and RSU in maintaining Trial Master File documentation and study records in accordance with SOPs. The role involves data tracking, filing, and supporting on-site activities.

The ideal candidate has a high school diploma, 3 years of admin experience, strong English communication skills, and proficiency with Word, Excel, and PowerPoint. This on-site role in Sydney offers collaboration with global teams.

Qualifications

• High School Diploma or equivalent.
• 3 years administrative support experience.
• Equivalent combination of education, training and experience.
• Proficient with Word, Excel and PowerPoint.
• Strong written and verbal English communication.
• Effective time management and organization.
• Ability to build good working relationships.
• Awareness of GCP and ICH guidelines.

Responsibilities

• Assist CRAs and RSU teams in updating and maintaining TMF documents.
• Prepare, handle, file and archive clinical documents per SOPs.
• Periodically review study files for completeness.
• Assist with tracking and distribution of Clinical Trial Supplies.
• Track and manage CRFs, queries and data flow.
• Serve as a central contact for project communications and documentation.
• May accompany CRAs on site visits after training.

Skills

Administrative support

Time management

Written communication

Verbal communication

English proficiency

Relationship building

Education

High School Diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

Microsoft 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.