Clinical Research Associate

Overview

Join Medpace as a Clinical Research Associate based in Auckland, New Zealand, where you will oversee and ensure compliance across various clinical trial activities. This role involves close interaction with clinical site staff and requires detailed verification and documentation aligned with protocols and regulatory standards.

Key Responsibilities

• Manage site qualification, initiation, monitoring, and closeout visits adhering strictly to approved clinical protocols.
• Effectively communicate with medical site personnel, including coordinators, clinical research physicians, and other team members.
• Confirm investigator credentials, training, and resource availability, encompassing facilities, labs, equipment, and staff capability.
• Audit medical records and source documentation to validate accuracy of case report form data, address errors, enforce proper documentation, and report protocol deviations per SOPs, GCP, and regulatory mandates.
• Ensure patient eligibility compliance during subject enrollment by investigators.
• Review regulatory documentation meticulously.
• Manage investigational product handling including accountability and inventory oversight.
• Scrutinize adverse event reports, medication use, and related health conditions for precise data reporting concordant with the protocol.
• Evaluate site patient recruitment and retention effectiveness and recommend strategies for improvement.
• Prepare detailed monitoring reports and follow-up correspondence summarizing key observations, deviations, deficiencies, and corrective recommendations.

Qualifications and Experience

• Degree in health or science discipline, coupled with 2 to 5 years of clinical monitoring experience.
• Strong understanding of clinical monitoring protocols and procedures, enabling clear representation in internal and external meetings, including business development engagements.