Senior Clinical Research Associate I

🔥 10 hours ago

🇻🇳 Vietnam – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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

• 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