Jenifer Smith

Jen brings over 10 years of experience in project managing multisite clinical trials across both university and private research sectors, overseeing trials from start-up to closure. With a PhD in Psychological Sciences, a graduate certificate in research commercialisation, and numerous academic publications, Jen offers a unique perspective on the entire clinical trial life cycle. This deep understanding of site operations and their challenges allows Jen to expertly manage site audits (including FDA, HREC, and sponsor audits) and site quality/risk indicators.

A skilled communicator, Jen leverages academic teaching experience to simplify complex workflows into clear, accessible training and SOPs. Jen is also instrumental in preparing clinical sites for upcoming changes in the Australian Clinical Trials landscape, including the National Clinical Trials Governance Framework (NCTCF), ICH-GCP Revision 3, and TGA inspections, ensuring processes are aligned with regulatory requirements.

Outside of work, Jen is currently studying Australian Sign Language (Auslan) and enjoys coaching a deaf-friendly junior netball team.