Clinical Trials Associate

Pacific Edge Limited; New Zealand; On-site; NZD 65,000 - 90,000; Full time

Job summary

Pacific Edge Limited in Dunedin, NZ is seeking a Clinical Trials Associate to support coordination and delivery of clinical studies, maintain study documentation, and liaise with sites and vendors. You will assist with study start-up and close-out, support reporting, quality checks, and regulatory compliance under ICH-GCP, with a life sciences degree and good communication skills.

A systematic approach, data management capabilities, and familiarity with electronic data capture systems are

Qualifications

• Bachelor's degree in life sciences or related discipline.
• Previous experience in a clinical trials associate or similar role is advantageous.
• Understanding of regulatory requirements and ICH-GCP guidelines.
• Strong document management and familiarity with SharePoint or EDC systems is preferable.
• Excellent communication and cross-functional teamwork.
• Systematic, proactive approach with good follow-through.

Responsibilities

• Assist with preparation, review, distribution, and maintenance of clinical study documentation (protocols, consent forms, Investigator Site Files, Trial Master Files).
• Support study activation, ongoing management, and close-out activities including reports, meeting materials, and follow-up actions.
• Help maintain inspection-ready documentation and support audits and regulatory inspections.
• Track deliverables, data queries, vendor activities, kits, samples, shipments, invoices, and inventory; escalate issues as needed.
• Facilitate communication between internal teams, study sites, and vendors to ensure timely progress.
• Assist with configuration, testing, and use of Electronic Data Capture systems and other study tools.
• Contribute to quality checks, data integrity, and continuous improvement across clinical study operations.
• Adhere to Pacific Edge's health, safety, quality, and compliance requirements.

Job description

Jora New Zealand will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

Pacific Edge Limited – Dunedin, South Island

Reporting to the Associate Director, Clinical Trial Management (ADCTM) you will support the coordination and delivery of Pacific Edge clinical studies. You'll maintain study documentation, support site and vendor communication, assist with study start-up and close-out activities, and contribute to reporting, quality, compliance, and process improvement initiatives.

Key responsibilities

• Assist with the preparation, review, distribution, and maintenance of clinical study documentation, including protocols, consent forms, amendments, Investigator Site Files, and Trial Master Files.
• Support study activation, ongoing study management, and close-out activities by preparing documentation, reports, meeting materials, minutes, and follow-up actions.
• Help maintain inspection-ready documentation and support audit and regulatory inspection activities by gathering materials and drafting responses under guidance.
• Track study deliverables, data queries, performance metrics, vendor activities, invoices, kits, samples, shipments, and inventory, escalating issues where needed.
• Support communication between internal teams, study sites, and vendors to help ensure study activities are coordinated and progressed in a timely way.
• Assist when needed, with the configuration, testing, and use of Electronic Data Capture systems and other clinical study tools.
• Contribute to quality checks, document control, data integrity, workflow improvements, and continuous improvement across clinical study operations.
• Work safely and in accordance with Pacific Edge's health, safety, quality, and compliance requirements.

About you

To be successful in this role, you’ll bring:

• A bachelor's degree in life sciences, healthcare, data management, or a related discipline.
• Previous experience in a clinical trials associate or similar role would be an advantage.
• An understanding of clinical study regulatory requirements and guidelines, including ICH-GCP.
• Confidence using document management systems and common software applications; SharePoint or Electronic Data Capture system experience would be an advantage.
• Strong communication skills and the ability to work effectively with cross-functional teams.
• A systematic approach, with good initiative and follow-through.

You must be eligible to work in New Zealand.

Preference to be based in Dunedin but may consider remote working for the right candidate

About us

At Pacific Edge, our mission is to improve outcomes for people affected by cancer through innovative diagnostic solutions. Be part of a purpose-led team supporting clinical studies that contribute to Pacific Edge's mission to improve outcomes for people affected by cancer.