Emily Birthisel Email & Phone Number

Australia

Australia

Melbourne, Victoria, Australia

Melbourne, Victoria, Australia

- Development, review, maintenance and tracking of essential study documents- Ensure all regulatory documents and study supplies are maintained during the lifecycle of any assigned project- Track device accountability logs, shipping information, and ensure adequate supplies are available at assigned clinical sites. - Management of Trial Master File (TMF) and Electronic Data Capture (EDC)- Ensure compliance with applicable regulations/standards, including but not limited to TGA and FDA regulations, ISO 14155, European Medical Device and Canadian regulations.- Manage regulatory authority applications and approvals that oversee research.- Implementation and development of Clinical Affairs Quality System- Site visits; site qualification, site initiation, interim monitoring and close out- Establishment of the Nutromics Diagnostics HREC and NHMRC registration- Logistics management for transport of investigational devices- Project budgets- Site coordinator overseeing operations, compliance and quality of the Nutromics Clinical Research Centre- Liaison with Research and Development for Clinical Strategy- Quality control and process improvement

Role responsibilities include- Working in line with client SOPs, SDEAs and PVS per project specific responsibilities. - ICSR processing in to GxP databases (utilisation of MEDDRA and IME) and case follow up activities. - Clinical trial case management.- Detection and management of SSIs.- Implementation and adherence to GvP, TGA, MedSafe and client territory guidelines including regulatory submission.- Client and regulatory compliance (quality checks and QMS).- Reconciliations with internal and external collaborators.- Training and mentorship.- Development of Work Instructions and SOP oversight.- Global and local literature surveillance.- Efficiency driven collaboration and process improvement.

Melbourne, Victoria, Australia

Understanding the link between hearing loss and dementia, with multisensory integration.

Research, Innovation And Commercialisation Office.

Geelong, Victoria, Australia

Certified, Clinical Research Associate

Activities and Societies: CCRA® (Certified Clinical Research Associate) is a credential formally recognizing clinical research.

Masters Of Biotechnology

Bachelor Of Science - Bs, Biochemistry And Molecular Biology

Scientific studies in Neurochemistry, Protein Structure and Function, Techniques for Molecular Science, and Genomics and Bioinformatics..