Job Description

📍Kuala Lumpur, Malaysia

Job Type: Full-time | Remote

Syneos Health, a global leader in biopharmaceutical solutions, is hiring an experienced Clinical Research Associate (CRA / Sr. CRA) to support clinical trials across Malaysia.

Responsibilities:

•  Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote)
•  Ensure compliance with ICH-GCP, regulatory requirements, and study protocols
•  Verify proper patient informed consent and data confidentiality
•  Perform source document review, CRF verification, and query resolution
•  Oversee Investigational Product (IP) handling, storage, dispensing, and reconciliation
•  Review and reconcile Investigator Site File (ISF) and Trial Master File (TMF)
•  Document monitoring activities via reports, letters, and logs
•  Support patient recruitment and site-level communication
•  Participate in investigator meetings and sponsor meetings
•  Provide audit-readiness support
•  Use clinical systems and technologies for data review and documentation
•  May train junior CRAs and support real-world late-phase studies

Qualifications:

•  Bachelor’s degree in a related field or RN, or equivalent experience
•  Strong knowledge of Good Clinical Practice (GCP/ICH) and relevant regulations
•  Excellent communication, presentation, and interpersonal skills
•  Strong computer literacy and ability to learn new systems
•  Ability to travel up to 75%

Application Link:

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