Sr. Clinical Research Associate

Job Location:

Bangkok Office (Udomsuk 37)

Job Description:

The Sr. 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.

Responsibilities:

• 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 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
• 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

Requirement:

• 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