Clinical Trials Assistant

5 days ago

Melbourne, Australia IQVIA Full time

IQVIA has an exciting opportunity available for a** Clinical Trials Assistant / CTA**. The role can be based out of Sydney or Melbourne.

As a Clinical Trials Assistant for a dedicated large Global Pharmaceutical you will provide administrative support to clinical projects and update clinical systems and databases. You will also assist with general administrative functions as required.

As a CTA you will have dedicated mentoring and receive structured quarterly reviews on performance, promotion, and bonus awards.

**Your responsibilities will include**:

- Assisting Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
- Assisting the clinical team in 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.
- Assisting CRAs/iCRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
- Assisting 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 and with required approval.
- May perform assigned administrative tasks to support team members with clinical trial execution

**Key Requirements**:

- Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of applicable protocol requirements as provided in company training
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
- Good written and verbal communication skills including good command of English language
- Effective time management and organizational skills

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