Clinical Research Associate

Medpace; Adelaide; On-site; AUD 85,000 - 110,000; Full time

Job summary

Medpace in Australia is seeking a Clinical Research Monitor to conduct site visits per protocol, ensure data integrity, and uphold regulatory compliance. You will liaise with site staff, verify qualifications and training, monitor safety events, and manage drug accountability.

The role emphasizes adherence to GCP, SOPs and timely monitoring reports, with collaboration across cross‑functional teams to secure high quality data in clinical studies.

Qualifications

• Bachelor's degree in a health or science related field.
• Prior 2 years of study coordinator/clinical research coordinator experience preferred.
• Knowledgeable about Clinical Monitoring practices and procedures in line with SOPs and GCP.

Responsibilities

• Perform qualification, initiation, monitoring and closeout visits at research sites per protocol.
• Communicate with site staff including coordinators and clinicians.
• Verify investigator qualifications, training, facilities, labs and staff.
• Verify source data and ensure good documentation practices and report protocol deviations per SOPs and GCP.
• Confirm eligible subject enrollment and conduct regulatory document review.
• Manage investigational product accountability and inventory.
• Review adverse event data for accurate reporting.
• Assess site recruitment and retention and suggest improvements.
• Complete monitoring reports and follow-up letters with findings and recommended actions.

Skills

Clinical Monitoring

Site Staff Communication

Regulatory Knowledge

Documentation Practices

Education

Bachelor's degree in a health or science related field

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.

Qualifications:

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