Impactful Clinical Trials Start-Up Coordinator

Optimal Clinical Trials; Auckland; On-site; NZD 60,000 - 75,000; Full time

Job summary

Optimal Clinical Trials in Auckland is seeking a highly organised Start Up Coordinator to join our team. You will prepare clinical trial documentation, coordinate ethics submissions, regulatory approvals, and site requirements to ensure studies are ready to commence on time.

Ideal candidates will have healthcare or clinical research experience, strong attention to detail, and the ability to manage multiple priorities while collaborating with investigators, sponsors, and ethics committees.

Qualifications

• Excellent organizational and coordination skills.
• Experience in healthcare, clinical research, medical administration, or another regulated environment.
• Ability to manage documentation, deadlines, and competing priorities.
• Strong communication and stakeholder relationship skills.
• Knowledge of ICH-GCP is advantageous.

Responsibilities

• Coordinate study start-up activities to support timely activation of clinical trials.
• Prepare and maintain study documentation, schedules, and study-specific guides.
• Responsible for ethics submissions, regulatory approvals, and amendments.
• Track study progress, documentation, and key milestones to keep activities on schedule.
• Collaborate with investigators, Study Coordinators, sponsors, ethics committees, and external vendors.
• Coordinate start-up meetings and the handover of studies to Study Coordinators.
• Maintain quality standards and support compliance with ICH-GCP guidelines.

Skills

Organisational skills

Communication skills

Stakeholder management

Attention to detail

Job description

Optimal Clinical Trials in Auckland is seeking a highly organised Start Up Coordinator to join our team. You will prepare clinical trial documentation, coordinate ethics submissions, regulatory approvals, and site requirements to ensure studies are ready to commence on time.

Ideal candidates will have healthcare or clinical research experience, strong attention to detail, and the ability to manage multiple priorities while collaborating with investigators, sponsors, and ethics committees.