Contractor CRA

Job overview

This contract role is focused on end-to-end project coordination and site management for clinical studies in New Zealand. The position covers site selection, start-up, monitoring, and close-out, and must be carried out in line with Tigermed or sponsor SOPs, ICH-GCP, GCP, and other applicable regulations.

The role also carries responsibility for making sure site-generated data is accurate, delivered on schedule, and managed within the approved budget.

Site management

• Support clinical study site selection, initiation, and monitoring activities.
• Carry out pre-study visits to confirm that proposed sites meet sponsor selection criteria, including sufficient capability and relevant experience.
• Plan and lead site initiation visits so site teams receive the training needed to start and run the study in compliance with the protocol and regulations.
• Verify that the Principal Investigator and site personnel follow all safety reporting obligations set out in the protocol, SOPs, ICH-GCP, and GCP.
• Monitor recruitment progress and work to ensure enrollment targets are met across assigned studies.
• Perform monitoring visits according to the SDV plan and SOPs, resolve site issues, and submit monitoring visit reports promptly.
• Coordinate delivery of study materials such as investigational product, non-drug supplies, equipment, and CRFs to sites for startup and ongoing study needs.
• Prepare the site-specific EC submission package and ensure it is submitted correctly.

Training

• Provide regular guidance to site teams on ICH-GCP, GCP, protocol requirements, and study-specific processes.
• Lead site initiation activities to confirm that the site fully understands the protocol and operational expectations.

Documentation

• Collect essential documents on time during study startup, conduct, and close-down, ensuring regulatory and protocol compliance.
• Keep investigator site files and trial master files current and properly organized.
• Complete study record archiving in accordance with sponsor and protocol requirements.

Drug safety

• Share safety updates with all participating sites according to SOPs and relevant regulations.
• Make sure serious adverse events are reported within the required timelines and in line with applicable procedures.

Finance and administration

• Complete budget finalization and secure the signed site contract before the site initiation visit.
• Ensure the study payment schedule is followed and keep the supporting documents and receipts on file.

Study tools and systems

• Keep study tools and systems updated accurately and on time.

Qualifications

A bachelor’s degree or higher in Medicine, Pharmacology, Biology, or a related field is required. Strong candidates may be considered even if they do not fit every listed requirement exactly.

At least 1 year of CRA experience is expected. Applicants should have a solid understanding of Good Clinical Practice and clinical trial operations, along with strong working knowledge of Microsoft Word, Excel, PowerPoint, and Outlook.