Clinical Research Associate II

🔥 16 minutes ago

🇻🇳 Vietnam – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Contribute to the selection of potential investigators • Support study start-up and regulatory maintenance, including site qualification visits and EC/IRB and regulatory submissions where required • Train, support, and advise investigators and site staff on study-related matters and Risk Based Quality Management principles • Confirm required site staff training, including ICH-GCP training, and maintain inspection readiness • Participate in Local Study Team meetings and National Investigators meetings as applicable • Initiate, monitor, and close study sites • Track patient recruitment and site quality/performance • Identify and resolve study-related issues and escalate them as appropriate • Update CTMS and other systems with study-site data • Manage study and drug supplies and drug accountability • Perform remote and onsite monitoring visits and remote data checks • Perform Source Data Review, CRF review, and Source Data Verification • Conduct Site Quality Risk Assessments and adapt monitoring intensity • Ensure timely data query resolution and work with data management on study-data quality • Ensure accurate and timely reporting of Serious Adverse Events and follow-ups • Prepare and finalize monitoring visit reports in CTMS and provide feedback to Principal Investigators • Follow up on outstanding site actions • Escalate systematic or serious quality issues, data privacy breaches, and compliance issues • Assist sites in maintaining inspection-ready Investigator Site Files • Support audits and regulatory inspections • Collect and upload essential documents to the eTMF and support quality-control checks • Prepare study documents for final archiving and completion of the local eTMF • Provide research-related information useful for the local market • Ensure compliance with AstraZeneca's Code of Ethics, company policies, procedures, and applicable regulations • Collaborate with local MSLs as directed

🎯 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 • Degree in a scientific discipline or health care, or an equivalent combination of education, training and experience • Ability to perform remote and onsite monitoring visits • Ability to comply with AstraZeneca procedural documents, SOPs, ICH-GCP, and local, national, and regional regulations • Ability to use CTMS, eTMF, and other study systems • Ability to manage study supplies, drug supplies, and drug accountability • Ability to perform Source Data Review, CRF review, and Source Data Verification

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule

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