Department
Health & Biotech
Category
Health & Biotech
Job type
Full-Time
Experience
Not Mentioned
Description
- Flexible working conditions – Opportunity to work from home and flexible working hours
- Visa sponsorship & transfer for qualified candidates already based in Australia
- Competitive transportation allowance
- Annual Merit increases
- Variable Compensation Bonus Plan – Lucrative bonus calculated directly from the number of visits you do
- Fast PACE® – Accelerated, tailored training program training program based on your experience
- No metric for minimum required days on site per month.
- Opportunity for cross-functional and CRA leadership positions – Lead CRA, CRA Manager, Clinical Trial ManagerA
Qualifications
Highest qualification: University
- Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol;
- Communication with the medical site staff including coordinators, clinical research physicians and their site staff;
- Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
- Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements;
- Verification that the investigator is enrolling only eligible subjects;
- Regulatory document review;
- Investigational product/drug accountability and inventory;
- Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
- Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement;
- Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.