CRA Levels II/Sr - FSP - Portugal

Thermo Fisher Scientific · Remote

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Clinical OperationsRemoteFull timeCompany career page

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Role summary

Thermo Fisher Scientific seeks a Clinical Research Associate Level II/Senior to conduct remote and on-site monitoring of investigational sites across clinical trials. The role involves assessing protocol compliance, managing documentation, performing data verification, and ensuring regulatory adherence to support trial integrity and subject safety.

What they're looking for

Bachelor's degree in life sciences or Registered Nursing certification with equivalent qualification
Approximately one year clinical research monitoring experience or PPD Drug Development Fellowship completion
Proficiency in ICH-GCP guidelines, applicable regulations, and clinical trial procedures
Strong critical thinking, root cause analysis, and risk-based monitoring skills
Demonstrated medical/therapeutic area knowledge and medical terminology understanding
Excellent written and oral communication skills for interdisciplinary collaboration
Valid driver's license where applicable

What you'll be doing

Conduct risk-based site monitoring visits to assess protocol and regulatory compliance through on-site and remote activities
Perform source data review, source data verification, and CRF review to ensure data accuracy and completeness
Identify deficiencies, apply root cause analysis, and implement corrective and preventive actions with sites
Initiate investigational sites, conduct investigator meetings, and manage trial close-out and material retrieval
Provide trial status updates, maintain essential documents, and facilitate communication across sites, sponsors, and project teams

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Date posted10 days ago

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