​The Clinical Research Associate (CRA) acts as a primary contact for key players in clinical trials, including investigators, site staff, sponsors, ethics committees and regulatory authorities. ​The CRA monitors and manages quality control of research projects, ensuring compliance with established protocols, Good Clinical Practice/Good Pharmacoepidemiology Practice, regulatory guidelines and regulations, and standard operating procedures. The CRA ensures accuracy and validity of data, and that the rights, safety, well-being of subjects are protected.  

The roles and responsibilities of the Clinical Research Associate include, but are not limited to, the following:

• Prepare and conduct study feasibility, site selection, study start-up, initiation, monitoring and close-out visits in accordance with standard protocol, regulatory requirements and good clinical practices
• Perform on-site and remote monitoring visits and site management in accordance with the monitoring plan
• Support the implementation of site recruitment plan and retention strategies
• Ensure the quality and integrity of site practices and that the study is conducted in compliance with the protocol, GCP, applicable laws and regulations and SOPs
• Write and submit monitoring visit reports of site findings
• Escalate compliance issues and implement corrective and preventive actions as appropriate
• Participate in investigators meetings as necessary
• Maintain required essential documents throughout the complete study cycle
• Establish regular lines of communication with the assigned sites, the sponsor company and internal project teams
• Ensure site adherence to study timelines, quality of site data and data query resolution
• Ensure all clinical trial management systems are complete, accurate and updated
• Participate in audit preparation and follow-up activities as necessary

• At minimum, a Bachelor’s degree in life science or health-related science
• Minimum of one year working experience in a pharmaceutical industry or clinical research organization; knowledge of vaccine development is an asset
• Knowledge of medical terminology and Good Clinical Practice (ICH GCP)
• Proficiency in Microsoft Office (eg. Excel, PPT, Word, etc)

• Fluent in written and spoken professional English and Thai
• Ability to think analytically
• Excellent communication and organizational skills
• Ability to work independently (remotely) and yet be a team player
• Possess a flexible approach to work
• A self-starter, well organized and with attention to detail while keeping a “getting the job done” mentality
• Focus on delivering high-quality results on time
• Sensitive to cross-cultural differences 
• Availability to travel domestically and internationally as required

You will join a young, very dynamic, and fast-growing private research organization. Our passionate, truly multicultural, and diverse team of more than 115 colleagues and nearly 40 nationalities include epidemiologists, data scientists, statisticians, data analysts, medical writers, safety and pharmacovigilance specialists, project managers and business support professionals spreading over 20 countries. 
 
We all work remotely, setting our own time schedule, based on a “getting the job done” mentality.  This has a positive impact in our work-life balance. Our headquarters are in Leuven (Belgium), but we also have local and regional offices located in Rotterdam (the Netherlands), Bogota (Colombia) and Bangkok (Thailand).  You may need to travel occasionally to our Leuven office. 
 
At P95, we are a collaborative and international team that works on diverse projects, topics, and clients and faces interesting challenges. There is a high level of empowerment, flexibility, autonomy as well as opportunities for research and development, to make things happen. We have an open culture of respect and inclusion. Consequently, we value self-reliance, initiative, and responsibility of everyone in our team to meet our internal and external customers’ expectations. Finally, our colleagues experience a strong sense of meaning and purpose driven by the scientific nature and impact of our work.

Visit our website www.p-95.com to learn more about who we are and what we do. If you are the one for this job, send your application by filling out the following short form. The call will remain open until the position is filled.

P95 is an Equal Opportunities Employer. The company is committed to equal employment opportunities regardless of age, sexual orientation, gender, pregnancy, religion or belief, union belief, wealth, birth, nationality, ethnic origin, disability, medical history, skin color, marital status, genetic information, parental status, social origin, or condition. We base all our employment decisions on merit, job requirements and business needs.