Clinical Trials Documentation & Compliance Assistant

IQVIA Inc; 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

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.