Clinical Research Associate

Medpace; Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

Medpace in Melbourne is seeking a Clinical Research Monitor to conduct qualification, initiation, monitoring and closeout visits at research sites in compliance with the approved protocol. You will communicate with site staff, verify investigator qualifications and resources, and ensure good documentation practices.

The role requires travel approximately 60-80% to nationwide locations (or less if remote/virtual visits), with strong communication and presentation skills, and a detail-oriented,

Qualifications

• Bachelor's degree in a health or science related field is required.
• 2 years of study coordinator experience preferred.
• Willing to travel 60-80% of the time to nationwide locations (or less for remote/virtual visits).
• Strong communication and presentation skills are essential.
• Must be detail-oriented and efficient in time management.

Responsibilities

• 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; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Skills

Communication skills

Presentation skills

Detail-oriented

Time management

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; and
• 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 experience is preferred;
• Willing to travel approximately 60-80% to locations nationwide is required, or less if remote/virtual visits;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management.