Clinical Research Associate Specialist

2 days ago


Brisbane, Queensland, Australia KlinEra Global Services Inc Full time
Job Title: Clinical Research Associate Specialist

Estimated Salary: $80,000 - $110,000 per year.

Company Overview:

KlinEra Global Services Inc is a leading provider of clinical research services. We are dedicated to delivering high-quality solutions that meet the needs of our clients and partners.

About the Role:

We are seeking a highly skilled Clinical Research Associate (CRA) to join our team. As a CRA, you will be responsible for managing clinical trials from initiation to completion, ensuring compliance with regulatory requirements and GCP guidelines.

Key Responsibilities:
  • Participate in study protocol review and development, collaborating with cross-functional teams to ensure seamless execution.
  • Assist in site selection and qualification, verifying sites' capabilities and ensuring availability of necessary study materials.
  • Develop study documents, including informed consent forms (ICFs) and study manuals, adhering to regulatory requirements.
  • Conduct site initiation visits (SIVs), training site staff on study protocols and procedures.
  • Verify site capabilities and ensure adherence to the protocol, GCP, and applicable regulatory requirements.
  • Review and verify data accuracy and completeness in source documents and case report forms (CRFs).
  • Track subject recruitment and enrollment status at clinical sites, ensuring timely resolution of data queries and discrepancies.
Requirements:

To succeed in this role, you will need:

  • Bachelor's degree in life science or a related field, with advanced degree preferred.
  • Minimum 3+ years of experience in the clinical research industry, with solid understanding of GCP guidelines and regulatory requirements.
  • Excellent organizational, communication, and interpersonal skills, with ability to manage multiple priorities and work effectively in a team environment.
  • Fluency in Mandarin is preferred, but we welcome applicants from diverse linguistic backgrounds.
What We Offer:

In addition to a competitive salary, we offer:

  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Ongoing professional development opportunities, ensuring you stay up-to-date with industry developments and best practices.
  • A collaborative and dynamic work environment, where your skills and expertise are valued and respected.


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