Clinical Research Associate II

🔥 3 minutes ago

🇻🇳 Vietnam – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• 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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