Veritus Research is an exciting new clinical trial business for First in Human, Phase 1 and vaccine clinical trials.
Our Trial Advancement team is expanding, and we are seeking for a Clinical Trials Study Start-up Specialist to join us at our state-of-the‑art clinical trials facility in Bayswater, Victoria. This is an extraordinary opportunity for an experienced clinical trial professional to support study start up activities at Veritus Research and contribute to creating effective processes.
Reporting to the TAT Manager and working very closely with the Project Teams, the Study Start-up Specialist will primarily be responsible for preparation and submission of HREC and RGO applications, overseeing essential document collection, vendor liaison, regulatory compliance and ensuring efficient and robust governance and start-up timelines of our growing trial portfolio.With an eye for detail and an understanding of GCP they will provide valuable support to the team to ensure adherence to best practice in research processes.
To be successful in the role you will:
Support the process that pre-empts repetitive HREC responses, resulting in a time reduction from HREC submission to approval.
Ensure HREC submission to SIV timelines are met.
Ensure the budget and CTRA negotiation timelines are met.
Implement processes that ensure full Governance approval (where possible) achieved prior to SIV.
To successfully achieve these outcomes, you will need to:
Maintain the highest quality and attention to detail while performing all tasks.
Meet or reduce Sponsor start-up timelines as required with efficient, quality‑driven work.
Educate and support the Project Management Team with all HREC and governance related activities.
Prepare and finalise vendor work orders and other documentation.
Ensure the accurate completion of the CTRA by utilising the CTRA checklist.
Prepare and submit all relevant documents to the VR Governance Team for approval.
Manage tasks as required based on the priorities set out by TAT Manager.
Ensure that each trial is ready to recruit in advance of the SIV date.
Professional Background:
2+ years of clinical trial experience
Tertiary qualifications in Medicine, Science (or equivalent)
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Clinical Trial Advancement Specialist (Study Start-Up) • Melbourne, AU
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