Clinical Trials Administrator (Start-Up Associate)

UniSC•UniSC Sunshine Coast, BC

3d•A$82,843 - A$93,358•Onsite

About The Position

UniSC has established a world-class Clinical Trials operation that is strengthening the region’s clinical research capability and delivering innovative, regionally relevant research in collaboration with healthcare professionals, pharmaceutical leaders and key industry stakeholders. As a Start-Up Associate, you will play a key role in supporting the successful delivery of clinical trial projects across the UniSC Clinical Trials network by providing high-level administrative and specialist support in the preparation, coordination and submission of start-up, regulatory and essential site documentation, ensuring projects are managed efficiently, compliantly and to the highest standard.

Requirements

Completion of a relevant degree, with relevant experience or an equivalent combination of experience and qualifications;
Sound knowledge of ICH Good Clinical Practice and applicable regulations;
High level computing skills (including databases, clinical trial electronic data entry, word processing and spreadsheets);
Sound understanding of privacy principles governing health information;
Ability to work independently and as part of a multidisciplinary team.

Responsibilities

Support the Regulatory and Start Up team to ensure all projects across the UniSC CT network achieve smooth transition from feasibility to recruitment within established timelines and quality standards.
Support the Regulatory and Start Up team in the ongoing management of study documentation and communication with/handover to the clinical team.
Provide administrative support to the Regulatory and Start Up Manager to assist in the overall management and compliance of regulatory and start up processes of the UniSC CT site network.