Clinical Research Associate
BioNet-Asia Co., Ltd.
jobsDB ref: JTH300003001202272
Employer Ref. Ploynaphat
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 steps to strengthen the clinical trial activities in the country.
The Clinical Research Associate will be supporting the clinical development department in all activities related to clinical trial preparation, 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.
- Assist clinical team for start-up of clinical studies including conducting site selection visits,preparing study-related documents such as study protocol,investigator’s brochure,informed consent forms,case report forms,and other document assigned by the Clinical Project Coordinator or Clinical Project Manager,ensuring IEC/IRB submission and obtaining approval for a study conduct within timeline,and setting up investigator meeting and intiation training.
- Assist clinical team to maintain and track revisions to all documentation for accuracy,including study logs,reports and relevant documents.
- 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.
- Encourage study sites to work in accordance with ICH-GCP, relevant guidelines and SOPs and within timeline.
- Perform and keep tracks on study monitoring, source document verification (SDV) and collection of data, and drug accountability to ensure GCP compliance , patient , safety ,and data accuracy
- 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 processs , amendment requests ,annual report, serious adverse event reports ,study reports ,and other documents required.
- Contribute to training activities as assigned.
- Contribute to the maintenance of the clinical SOP quality system.
- Perform other duties as required.
- 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 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 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
BioNet offers a very supportive work environment and excellent professional standards and work ethics. You will work in a very dynamic and nurturing environment where you will have the opportunity to demonstrate your talent and follow a rewarding career path.
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.
81 Moo 1, Baan Lane, Bang Pa-In,
*All applications will be accepted by mail attached in MS.Word only.
jobsDB will send your application for review directly to BioNet-Asia Co., Ltd.
About BioNet-Asia Co., Ltd.
A unique opportunity exists to join BioNet-Asia Co. Ltd (BioNet), the only independent biotech company in Thailand focusing on the discovery, development, and supply of innovative vaccines.
BioNet has started its R&D activities in 2007 and now has more than one hundred employees. The company has a significant pipeline of products in R&D and clinical stages and has filed a patent application for a new Recombinant Acellular Pertussis Vaccine which is about to enter Phase I clinical trial in Thailand and Europe.
Over the years, BioNet has also created several strategic alliances fostering vaccine self-reliance and leading to the production and supply of billions of doses of vaccines on all continents. We search for individuals taking pride in their work and the difference they make contributing to save the lives of millions of children around the world.