Senior Clinical Research Associate I
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Job Description
Senior Clinical Research Associate monitoring AstraZeneca clinical trials and study sites remotely in Vietnam. Managing site performance, regulatory compliance, data quality, and monitoring activities.
Responsibilities:
- Deliver clinical studies at allocated sites and participate in local study teams
- Serve as the main contact for study sites and monitor study conduct
- Prepare, initiate, monitor, and close assigned clinical study sites
- Contribute to investigator selection and study start-up activities
- Support regulatory submissions and maintenance with EC/IRB and Regulatory Authorities where required
- Train, support, and advise investigators and site staff on study-related matters and RbQM principles
- Confirm required site-staff training and maintain inspection readiness
- Participate in Local Study Team and National Investigators meetings as applicable
- Drive site performance and resolve or escalate study-related issues
- Update CTMS and other systems with study-site data
- Manage study supplies, drug supplies, drug accountability, and drug destruction where applicable
- Perform remote and onsite monitoring visits and remote data checks
- Perform SDR, CRF review, SDV, site quality risk assessments, and adapt monitoring intensity
- Ensure timely query resolution and collaborate with data management on study-data quality
- Report Serious Adverse Events and follow-ups accurately and promptly
- Prepare and finalize monitoring visit reports and provide feedback to Principal Investigators
- Follow up on outstanding site actions
- Escalate quality issues, data privacy breaches, CSP, or ICH-GCP compliance issues
- Assist sites in maintaining inspection-ready ISFs
- Collaborate on audits and regulatory inspections
- Collect and upload essential documents to the eTMF and support QC checks
- Ensure study documents are ready for final archiving and eTMF completion
- Provide research-related information useful for the local market
- Ensure compliance with AstraZeneca’s Code of Ethics, policies, procedures, and applicable legislation
- Collaborate with local MSLs as directed
Requirements:
- Minimum 3–5 years’ experience as a monitor
- Ability to work independently and monitor all stages of a study, across different phases
- Often has special therapeutic expertise
- Ability to take on LSL tasks and support the LSL in coordination or document preparation as required
- Ability to travel internationally as required
- Valid driving license
- Compliance with ICH-GCP, AZ Procedural Documents, AZ SOPs, local, national and regional legislation, and AstraZeneca policies and procedures
- Ability to perform clinical research monitoring, including SDR, CRF review, SDV, remote data checks, site quality risk assessments, and monitoring visits
- Ability to manage study supplies, drug supplies, and drug accountability
- Ability to use CTMS, eTMF, and other study systems
- Ability to support regulatory submissions, study start-up, and regulatory maintenance where required
- Ability to train and advise investigators and site staff
- Ability to ensure timely reporting of Serious Adverse Events and follow-ups
Benefits:
- Fully remote work arrangement
- Full-time employment
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