Malaysia CRA (Clinical Research Associate)
A global pharmaceutical company in Malaysia is looking for an experienced Senior CRA to join their dynamic team. This organisation is dedicated to becoming a global leader in the discovery, development, and commercialization of drugs for the treatment of cancer.
- Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guidelines.
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits, ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance.
- Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Assesses site processes, Conducts Source Document Review of appropriate site source documents and medical records
Skills and Requirements
- Must be educated to degree level in a life science discipline or be a licensed healthcare professional.
- Must have worked in global companies and managed global or regional studies in Taiwan.
- Mandatory to be fluent in English to manage global studies trials
Please click on the Apply button.