P95, an Ampersand portfolio company, is a global provider of clinical research and epidemiology solutions focusing on vaccines and infectious diseases.
Founded in 2011, we are a leader in sourcing, analysing, and reporting epidemiological data to assist health agencies and pharmaceutical companies in improving access to safe and effective vaccines. We have offices in Europe, Latin America, and SE Asia.
We are passionate about healthcare and helping our customers with innovative medical research. We share a sense of urgency with our customers to deliver timely, pragmatic and useful insights to improve healthcare.
Our clients are from the pharmaceutical industry, public health institutes, academic institutions, WHO, the European Commission and other governmental organizations and Non-Governmental Organizations (NGOs). Our projects focus mainly on infectious diseases, particularly on vaccines.
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