Clinical Research Associate

4 weeks ago

Sydney, New South Wales, Australia Buscojobs Full time
1.
Job Purpose This position is responsible for project management and study site management from site selection to initiation, monitoring, and close-out of assigned clinical studies in accordance with Tigermed or sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice standard (ICH-GCP), Clinical Practice standard (GCP), and other applicable regulations.
The position is responsible for ensuring that all data generated by the assigned sites is of high quality, on time, and within budget.2.
Responsibilitiesa) Site management Study site selection, initiation (SIV), and clinical monitoring.
Perform pre-study visits to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
Ensure Principal Investigator / study staff comply with safety reporting requirements, as defined in protocol, SOP, ICH-GCP, and GCP.
Track study recruitment to ensure recruitment targets are achieved in all studies.
Conduct monitoring visits according to SDV plan and SOP; address issues with sites and complete monitoring visit reports in a timely manner.
Ensure timely coordination of study materials (drug, non-drug, equipment, CRFs) to the site for start-up and throughout the study.
Assemble site-specific EC submission dossiers and ensure submission to EC.
Training Provide ongoing training to site staff regarding ICH-GCP, GCP, study protocol, and requirements.
Conduct site initiation visits to ensure that the site has a thorough understanding of the study protocol and requirements.
Documentation Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during, and at study close-down.
Maintain and update these documents in investigator files and trial master files.
Prepare and complete study records' archiving according to protocol and sponsor requirements.b) Drug Safety Ensure safety information is disseminated to all sites according to SOP and applicable regulations.
Ensure Serious Adverse Event (SAE) reports are submitted within the required timelines in compliance with SOPs and regulations.c) Finance and Administration Finalize budget and obtain signed contracts from sites prior to site initiation visits.
Ensure study payment schedules are executed and relevant documents/receipts are retained.d) Study Tools and Systems Update and maintain study tools and systems in a timely manner.3.
Qualifications Bachelor's degree or higher in Medical, Pharmacology, or Biology related major.
Exceptional candidates not meeting current requirements may also be considered.
At least 1 year of CRA experience.
Good understanding and knowledge of GCP and clinical trial operation processes/procedures.
Proficiency in Microsoft Word, Excel, Power Point, and Outlook.
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