Clinical Research Associate

Medpace; Sydney; On-site; AUD 80,000 - 110,000; Full time

Job summary

Medpace is seeking a Clinical Research Monitor in Sydney to conduct qualification, initiation, monitoring and closeout visits in accordance with the protocol. You will engage with site staff, verify investigator qualifications and resources, and ensure accurate documentation and regulatory compliance.

The role involves data verification against CRFs, regulatory document review, and monitoring site recruitment performance, with follow-up recommendations to secure protocol adherence.

Qualifications

• Bachelor's degree in health or science.
• 2 years of study/coordinator experience preferred.
• Knowledge of clinical monitoring practices for internal/external meetings.

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits per protocol.
• Communicate with site staff including coordinators and physicians.
• Verify investigator qualifications, training, facilities, equipment.
• Verify data entry against case report forms and ensure good documentation practices.
• Regulatory document review and drug accountability.
• Assess site recruitment and retention; suggest improvements.
• Complete monitoring reports and follow-up letters with summaries of findings and actions.

Skills

Communication

Clinical monitoring

Documentation

Regulatory knowledge

Education

Bachelor's degree in health or science

Job description

• 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.

Requirements:

• Bachelor's degree in a health or science related field;
• Prior 2 years of study coordinator/clinical research coordinator experience is preferred;
• Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external (e.g., business development) meetings.