Clinical Research Associate: Site Leader & Growth Driver

Merck

New Zealand

On-site

NZD 70,000 - 110,000

Full time

5 days ago
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Job summary

Merck in Auckland, New Zealand, is seeking aClinical Research Associate (CRA) to ensure site performance, compliance with ICH-GCP, and robust data integrity across assigned protocols. The role reports to the CRA Manager and focuses on site management, regulatory documentation, and investigator collaboration.

You will monitor sites, support start-up and close-out activities, and help grow the clinical research territory while collaborating with cross-functional teams to uphold quality and patient

Qualifications

  • For this CRA role, direct site management experience in bio/pharma/CRO is required.
  • Strong knowledge of GCP/ICH requirements and local regulatory guidelines.
  • Hands-on documentation practices and regulatory file handling.
  • Proven monitoring capability and ability to work independently.
  • Ability to manage multiple sites, protocols, and timelines with accuracy.
  • Fluent in local language and English, with strong written communication.

Responsibilities

  • Act as primary site contact and site manager for allocated sites.
  • Develop and maintain strong site relationships across trial phases.
  • Perform site management and monitoring in compliance with ICH-GCP and protocol.
  • Coordinate site readiness activities with sponsor functions.
  • Participate in site selection and validation activities.
  • Conduct remote and on-site monitoring to ensure data integrity and safety.
  • Prepare visit reports and regulatory documentation for start-up, maintenance, and close-out.
  • Communicate with investigators and site staff on protocol conduct and audits.

Skills

Site management
Monitoring
ICH-GCP compliance
Data interpretation
Communication
Time management
Independent judgment
Problem solving

Education

Associate degree / certificate in scientific or healthcare discipline
Bachelor’s degree or higher in science/healthcare

Tools

CTMS
eTMF
MS Office

Job description

Merck in Auckland, New Zealand, is seeking aClinical Research Associate (CRA) to ensure site performance, compliance with ICH-GCP, and robust data integrity across assigned protocols. The role reports to the CRA Manager and focuses on site management, regulatory documentation, and investigator collaboration.

You will monitor sites, support start-up and close-out activities, and help grow the clinical research territory while collaborating with cross-functional teams to uphold quality and patient

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