Location: Melbourne, Adelaide, Perth FTE: 0.5-1 FTE Start date: ASAP Contract length: 12 months JOB DESCRIPTION / SUMMARY This role will ensure studies are monitored in accordance with the clinical protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements. RESPONSIBILITIES The main responsibilities of this role include, but are not limited to, the following: Independently conduct monitoring visits at investigational sites, including site evaluation, initiation, interim, motivational (as applicable) and close-out visits. Prepare and submit monitoring visit reports in accordance with SOPs. Conduct co-monitoring visits at investigational sites, as needed. Obtain, collate, and file essential clinical documents in accordance with SOPs. Communicate project-specific information to and from trial sites and document communications with study site and team. Escalate and triage issues to team in a timely manner. Manage key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out. Train investigational site personnel to the clinical protocol and protocol-related plans, manuals, and guidance documents as well as industry standards including ICH-GCP. Train investigational site personnel on any study-specific portals or vendors, if applicable. Identify and resolve data discrepancies. EDUCATION AND EXPERIENCE REQUIREMENTS Bachelor’s degree or equivalent experience in relevant field (science, nursing, medical or pharmacy degree required) At least 5 – 7 years previous CRA experience in a CRO or biotech/pharmaceutical industry. KNOWLEDGE & SKILL REQUIREMENTS Knowledge of applicable standards, regulations and ICH-GCP for clinical study conduct Willingness to travel up to 75% of the time Willingness to be compliant with study-specific billing and budgetary constraints
