Clinical Trials Assistant

About the role

iQVIA, a global provider of clinical research services, is looking for a Clinical Trials Assistant in North Sydney. The role supports Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) team by keeping clinical documents and systems up to date, and by helping manage clinical documentation, trial supplies and case report forms.

Key responsibilities

• Update and maintain clinical documents and systems such as the Trial Master File (TMF) so they track site compliance and performance within project timelines.
• Prepare, handle, distribute, file and archive clinical documentation and reports according to the scope of work and standard operating procedures.
• Review study files periodically for completeness.
• Help prepare, handle and distribute clinical trial supplies and maintain tracking information.
• Track and manage Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for project communications, correspondence and related documentation.
• May accompany CRAs on site visits to assist with clinical monitoring after completing required training.

Required profile

• High School Diploma or equivalent, or an equivalent combination of education, training and experience.
• At least 2 years of administrative support experience in clinical trials.
• Good written and verbal communication skills, including a good command of English.
• Effective time management and organisational skills.
• Ability to build and maintain good working relationships with coworkers, managers and clients.
• Awareness of clinical research regulatory requirements such as Good Clinical Practice (GCP) and ICH guidelines, as covered in company training.
• Knowledge of protocol requirements as covered in company training.

Required skills

• Working knowledge of Microsoft Word, Excel and PowerPoint.