Clinical Research Associate II
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Job Description
Clinical Research Associate monitoring AstraZeneca clinical trial sites in Vietnam. Supporting study start-up, site performance, regulatory compliance, data quality, and inspections.
Responsibilities:
- Support delivery of clinical studies at allocated sites as an active participant in local study teams
- Serve as the main contact with study sites and monitor study conduct
- Prepare, initiate, monitor and close assigned clinical study sites
- Contribute to investigator selection and, where required, study start-up and regulatory maintenance
- Train, support and advise investigators and site staff on study-related matters and RbQM principles
- Confirm required site-staff training and inspection readiness
- Participate in local study team and national investigator meetings
- Drive site performance, resolve study-related issues and escalate as appropriate
- Update CTMS and other systems with site data
- Manage study, drug supplies and drug accountability
- Perform remote and onsite monitoring visits, remote data checks, SDR, CRF review and SDV
- Conduct site quality risk assessments and adapt monitoring intensity
- Ensure timely data-query resolution and accurate Serious Adverse Event reporting
- Prepare monitoring visit reports and provide feedback to Principal Investigators
- Follow up on outstanding site actions
- Escalate quality, privacy and compliance issues
- Assist with inspection readiness, audits and regulatory inspections
- Collect and upload essential documents to the eTMF and support quality-control checks
- Ensure study documents are ready for archiving and eTMF completion
- Provide research-related market feedback and collaborate with local MSLs
- Ensure compliance with company policies, ethics requirements and applicable regulations
Requirements:
- 0–2 years of prior relevant experience
- Good knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Written and verbal communication skills
- Good command of English language
- Degree in a scientific discipline or health care
- Equivalent combination of education, training and experience may be accepted in lieu of degree
Benefits:
- Fully remote work arrangement
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