Clinical Trials Co-ordinator

The Clinical Trials Coordinator manages all participant-related activities for Commercial and Investigator-Initiated Clinical Trials, working with the Principal Investigator and trial team from start to finish. They ensure recruitment and timelines are met, maintain participant safety, and ensure compliance with regulatory and ICH GCP guidelines.

Permanent Full Time Clinical Trial Co-ordinator Roles

Job Details:

• $37.50 - $44 per hour based on experience and/or qualification
• 40 hours per week
• Flexibility to work across our centres between Middlemore Hospital and Whangarei Hospital

What we offer:

Excellent team environment with strong company values - Kind, Excellence, Respect and Passion Employee shares, at no cost, for permanent employees.

Access to a range of generous staff discounts including medical insurance, banking, gym membership, retail, and many more.

Training opportunities available both within the organisation, and through external providers to maintain professional practice and knowledge

Opportunities for ongoing development and career progression – we love seeing our team grow!

What you'll be doing:

• Works with the team to review protocols, identify issues, support feasibility assessments, and help prepare for trial start-up. They understand the trial’s purpose and treatment, screen and recruit suitable participants, and support the informed consent process per GCP and SOPs.
• Ensures all trials comply with ICH-GCP guidelines, supports ethics and internal approvals, and keeps regulatory documents up to date. They assist sponsors, monitors, and auditors during site reviews, report adverse and serious events within required timeframes, and help prepare the Annual Report.
• Supports clinical trial development and identifies additional trial-related activities
• Understands the importance of the Treaty of Waitangi and Māori values, demonstrating cultural sensitivity and safety in all interactions. They acknowledge the diverse backgrounds of participants and apply this awareness when recruiting and managing trial participants.
• Actively participates in staff meetings and ensures that any initiatives and changes are implemented in a timely manner
• Aware of their responsibilities under the Health and Safety in Employment Act 2015 and actively identifies, reports, and helps manage workplace hazards. They monitor their own health and safety, report concerns, and follow incident reporting procedures, including the CAPA process.
• Maintains current certification in ICH-GCP, Dangerous Goods Training - IATA, Basic Life Support and Patient Safety Training.
• Knowledge of internet-based software and the ability to learn about electronic CRF (clinical record form) submissions and other electronic data recording processes required for clinical research.

What you'll bring:

• PhD in science preferred, must have MSc in health, medical science or science field and/or equivalent experience in commercial trial clinical trial management
• Knowledge of medical terminology, anatomy, and physiology
• Previous research trial coordination experience preferred
• Knowledge of the Treaty of Waitangi and Maori Core Values
• Excellent written and verbal communication skills, problem solving skills, and attention to detail
• Ability to apply common sense/understanding to carry out instruction furnished in written oral or diagram form
• Competent in the use of information technology including Microsoft Office and Outlook, conversant with leading edge information technology preferred
• Ability to read and interpret documents such as the SOP and maintenance instructions and procedure materials
• Ability to critique and use clinical research findings preferred
• Ability to work autonomously to achieve targets and to work cooperatively ina multidisciplinary team
• With current clean drivers licence