Clinical Research Associate

Medpace; Auckland; On-site; NZD 80,000 - 110,000; Full time

Job summary

Medpace in Auckland, New Zealand, is seeking a Clinical Research Associate to conduct site visits and ensure protocol compliance across monitoring activities. The role emphasizes quality data, regulatory adherence, and site staff collaboration.

The ideal candidate holds a bachelor’s degree in health or science and 2–5 years of clinical monitoring experience, with strong communication and GMP/GCP knowledge. This position offers opportunities in a globally connected CRO environment.

Qualifications

• Bachelor's degree in a health or science related field and with at least 2 to 5 years of experience in clinical monitoring.
• Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external meetings.

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.
• 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

Clinical monitoring

Regulatory compliance

GCP & documentation

Site staff communication

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.

Qualifications:

• Bachelor's degree in a health or science related field and with at least 2 to 5 years of experience in clinical monitoring;
• Knowledgeable about Clinical Monitoring practices and procedures to represent the function in internal and external (e.g., business development) meetings.