FSP Senior CRA

Thermo Fisher Scientific · Singapore

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Clinical OperationsFull timeCompany career page

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Role summary

Thermo Fisher Scientific seeks a Senior Clinical Research Associate to monitor complex oncology and cell/gene therapy trials across investigator sites. The role involves conducting remote and on-site visits, ensuring protocol compliance, managing documentation, and maintaining audit readiness across global clinical studies.

What they're looking for

Bachelor's degree in life sciences or equivalent
Minimum 3–5 years independent clinical monitoring experience
Required experience in oncology and/or cell and gene therapy studies
Strong knowledge of ICH-GCP guidelines and applicable regulations
Proficiency in Microsoft Office and clinical systems (Veeva eTMF, CTMS, EDC)
Demonstrated risk-based monitoring principles and root cause analysis skills
Excellent communication and stakeholder management abilities

What you'll be doing

Conduct risk-based monitoring at investigator sites using root cause analysis to identify and resolve compliance issues
Verify data accuracy through source document review, verification, and case report form assessment
Evaluate investigational product handling, storage, and accountability procedures
Document observations in timely reports and escalate deficiencies to clinical management for resolution
Support site initiation, qualification, and close-out activities; participate in investigator meetings

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Date posted7 days ago

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