- Bangkok Office (Udomsuk 37) & Ayutthaya
- The Clinical Research Associate (CRA) ensures the highest quality review of data and effective interaction with
- study sites. They conduct on-site monitoring visits throughout the study to ensuring the quality of the clinical
- research. The Sr. CRA also performs and coordinates all aspects of the clinical monitoring and site management
- process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and BioNet Standard
- Operating Procedures.
- Conducts site visits to assess protocol and regulatory compliance and manages required documentation
- Responsible for ensuring that data will pass international quality assurance audits
- Represents BioNet in the global medical research community and develops and maintains collaborative relationships with investigational sites
- May assist project manager or clinical team managers on assigned project
- Assist clinical team for start-up of clinical studies including conducting site selection visits, preparing studyrelated 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
- 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
- Minimum of three to five (3-5) 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 in Thai and English, 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.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
- Ability to travel
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
*All applications will be accepted by mail attached in MS. Word only.