Scientific Study Coordinator

1 week ago

Sydney, New South Wales, Australia beBeeResearch Full time US$90,000 - US$120,000
Clinical Research Associate Job Description

Linical Co., Ltd. is a global Contract Research Organization (CRO) headquartered in Osaka, Japan, dedicated to serving its clients as a true partner in development. With over 700 employees across more than 20 countries, we offer individualized solutions tailored to the specific needs of our sponsors.

We work as integrated teams functioning with maximum transparency throughout each study, ensuring that the sponsor is kept up-to-date on all study parameters and progress. Our team is dedicated to the highest standards of quality, with a special focus on therapeutic areas such as oncology, immunology, and CNS, based on experience and expertise.

Job Responsibilities:

  • Ensure compliance with the approved study protocol/amendment(s), ICH GCP, SOPs, and regulatory requirements in assigned countries.
  • Conduct monitoring visits (pre-study, initiation, routine monitoring, site closure).
  • Review and/or input to the study protocol, CRF, and validation tools.
  • Prepare and/or review Monitoring Guidelines, CRF Completion Guideline, patient information documents.
  • Prepare submissions to Independent Ethics Committees (central and local) and Competent Authorities.
  • Assist Investigators and Institutions with contracts, negotiate budgets, and arrange site payments.
  • Manage queries in cooperation with the Clinical Data Management Team.
  • Coordinate sites and study teams in managing contacts to external service providers.
  • Participate in feasibility studies and Investigator selection.

Required Skills and Qualifications:

  • University degree in sciences or related fields.
  • At least 2 years of experience as a Clinical Research Associate in a pharmaceutical company or CRO.
  • Strong knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements.
  • Fluent in English.
  • Strong team player with excellent communication and organizational skills.
  • Travel availability.

Benefits:

Join a dynamic and growing organization with opportunities for professional growth and development. Collaborate with a talented team of experts in the field of clinical research.

How to Apply:

Submit your application, including your resume and cover letter, to [insert contact information]. We look forward to receiving your application

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