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12 November 2019
Job ID: AY-2589
CRA-Clinical Research Associate

Job Description:

The Clinical Research Associate will be supporting the Clinical Development Department in all activities related to clinical trial preparation (startup), implementation and completion, ensuring the quality of the clinical research, and significantly contributing to the clinical operations quality system at BioNet in compliance with ICH GCP standards and relevant guidelines.

Responsibilities:

  • Assist clinical team for start-up of clinical studies including conducting site selection visits, preparing study-related documents such as study protocol, informed consent forms, case report forms, and other documents. Manage ethics submission to obtain approval for a study within timeline.
  • Perform clinical operation activities including investigational product management, biological sample management, and conducting site monitoring visits with proper documentation to ensure that the trial is performed in compliance to the study protocol, ICH-GCP, relevant guidelines and regulations.
  • Coordinate for study site management activities, communication, and issue resolution from start up to close out of each trial.
  • Plan and implement patient recruitment strategies in collaboration with the investigators and site staff
  • Coordinate for communication with Ethics Committees and regulatory agencies for submission process, amendment requests, annual report, serious adverse event reports, study reports, and other documents
  • Monitors study activity and prepare report to Project Manager as appropriate.

Requirement:

  • Minimum of two (2) years prior clinical monitoring experience.
  • Bachelors’ or Master Degree in health or science-related discipline.
  • Demonstrate knowledge of Thai and international clinical research regulations and guidelines such as ICH-GCP.
  • Must demonstrate good computer skills.
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
  • Good management skills.
  • Ability to work well independently as well as part of a team.
  • Self-starter with strong work ethics, values and a positive attitude.
  • Ability to travel
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Job Details:

Benefits:
  • Five-day work week
  • Medical insurance
  • Life insurance

BioNet-Asia Co., Ltd.
http://www.bionet-asia.com/

About BioNet-Asia Co., Ltd. BioNet-Asia is a vaccine company with fully integrated operations from research to manufacturing and distribution. For the last 15 years, the company has been focusing on biotech innovation and global market access. BioNet has successfully built many partnerships leading to the supply of hundred millions of doses of vaccines every year worldwide.

 

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