Clinical Research Associate

Role overview

Medpace is looking for a Clinical Research Associate based in Auckland, New Zealand. The role focuses on on-site clinical trial monitoring, site coordination, protocol compliance, and accurate study documentation across research locations.

Key responsibilities

• Carry out site qualification, study initiation, routine monitoring, and site closeout activities in line with the approved protocol.
• Maintain regular communication with site personnel, including coordinators, clinical investigators, and supporting clinical staff.
• Check that investigators and site teams have the right qualifications, training, facilities, equipment, laboratory access, and staffing needed to run the study properly.
• Compare medical records and source documents with case report form entries, flag data entry issues, reinforce sound documentation practices, and escalate protocol deviations in accordance with SOPs, GCP, and relevant regulations.
• Confirm that only eligible participants are enrolled in the study.
• Review regulatory documents to ensure the site remains compliant.
• Track investigational product and drug stock, including accountability and inventory control.
• Review adverse events, serious adverse events, concomitant medications, and related conditions to ensure accurate reporting as required by the protocol.
• Evaluate how well the site is recruiting and retaining patients and suggest practical ways to improve performance.
• Prepare monitoring reports and follow-up letters that summarize key findings, deviations, deficiencies, and corrective actions needed to maintain compliance.

Requirements

• A bachelor's degree in a health-related or science-related discipline is required.
• 2 to 5 years of experience in clinical monitoring is expected.
• Strong knowledge of clinical monitoring processes and procedures is needed to represent the function in internal meetings and external discussions, including business development conversations.

Additional information

This is a full-time onsite role in Auckland, New Zealand. The source provided no details on compensation, benefits, application deadline, number of openings, or start date.