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18 June 2019
Job ID: AY-1729
Clinical Research Associate

The opportunity:

BioNet is looking for a highly motivated, dynamic and talented individual to join its Clinical Development Department.

This is a permanent position in the Clinical Development Department led by an international clinical development leader to collaborate with academic organizations around the globe for clinical trials related activities.The Clinical Research Associate will be pivotal in developing clinical research operations starting from Phase I for new vaccines developed and produced in Thailand. This is one of the key step to strengthen the clinical trial activities in the country.

Job Summary:

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

  • Assists clinical team for start-up of clinical studies including site selection visits, preparing study-related documents such as study protocol, informed consent forms, case report forms, and other documents. Manages ethics submission to obtain approval for a study within timeline.
  • Performs clinical operation activates 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 regulation.
  • Coordinates for study site management activities, communication, and issue resolution from start up to close out of each trial.
  • Plans and implements patient recruitment strategies in collaboration with the investigators and site staff.
  • Coordinates for communication with Ethics Committees and regulatory agencies for submission process, amendment requests, annual report, serious adverse event reports, study reports, and other documents required.
  • Coordinates plans, and implement as study requirement; monitors study activity and prepares reports to sponsors as appropriate.

Ideal candidate:

  • Minimum of two (2) years prior clinical monitoring experience.
  • Bachelors’ or Master Degree in a health or science-related discipline.
  • Fully fluent spoken and written English.
  • A keen interest in vaccinology, clinical trials, and immunology.
  • Demonstrates knowledge of Thai and international clinical research regulations and guidelines such as ICHGCP.
  • 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 multitask and deliver on multiple projects.
  • 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.

Working location:

  • Can be based either in (1) BioNet-Asia Head Office at Udomsuk 37, Sukhumvit 103 Rd., Bangjak, Prakanong, Bangkok 10260 or (2) BioNet-Asia Branch 1 at Hi-Tech Industrial Estate, Bang Pa-In, Ayutthaya 13160

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.

To Apply : Please submit your resume in MS Word with recent photo stating present and expected salary by click "Apply Now"

Human Resources Department

BioNet-Asia Co., Ltd.    

Plant:Hi-Tech Industrial Estate, 81 Moo 1,Baan-Lane,Bang Pa-In,

Ayuttaya 13160 Thailand

 Website: www.bionet-asia.com

*All applications will be accepted by mail attached in MS.Word only.


Job Details:

Benefits:
  • Five-day work week
  • Performance bonus
  • Free shuttle bus
  • 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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