Thermo Fisher Scientific
Thermo Fisher Scientific
Thermo Fisher Scientific develops and delivers technologies, laboratory products, and pharmaceutical services that support scientific research and healthcare. Its work spans life sciences research, analytical problem-solving, laboratory productivity, diagnostics, and the development and manufacturing of therapies. The company serves customers through a global team and a portfolio of brands including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. Its careers encompass the scientific, healthcare, manufacturing, logistics, and service operations behind these offerings.

Clinical Research Associate II / Senior CRA – Oncology (Oregon Remote)

Clinical Research Associate II/Senior CRA supporting oncology trials for Thermo Fisher Scientific. The role covers site monitoring, compliance, data quality, documentation, and audit readiness through frequent travel.

Description

  • Lead and coordinate clinical monitoring and investigator-site management activities
  • Perform remote and onsite visits to evaluate regulatory compliance and maintain required documentation
  • Verify that studies follow approved protocols, ICH GCP, applicable regulations, and standard operating procedures
  • Support audit readiness while building effective working relationships with investigator sites
  • Apply risk-based monitoring methods across investigator sites
  • Use root cause analysis and structured problem-solving to identify site process issues and define corrective and preventive actions
  • Protect data quality through source-document review, source-data verification, and case-report-form review
  • Review investigational-product inventories and supporting records
  • Record monitoring findings in reports and letters, escalating deficiencies to clinical management
  • Stay engaged with sites between visits and track open issues through resolution
  • Complete monitoring activities in line with approved monitoring plans
  • Support investigator payment activities and shared issue-resolution responsibilities
  • Track study progress and report status updates to the Clinical Team Manager
  • Maintain clinical study systems, including CTMS, and quality-check CTMS reports
  • Attend investigator meetings and help identify potential investigators with client companies
  • Initiate study sites and provide recommendations on site compliance
  • Complete study closeout activities and coordinate retrieval of trial materials
  • Confirm essential documents are complete and conduct onsite file reviews
  • Support publications, study tools, trip-report reviews, newsletters, and CRA team calls
  • Coordinate communication among investigator sites, client companies, and the PPD project team
  • Address company, client, and regulatory requirements, including audits and inspections
  • Handle administrative duties such as expense reporting and timesheet completion
  • Contribute to process-improvement initiatives and additional project work

Requirements

  • Bachelor’s degree in a life sciences discipline, Registered Nurse certification, or an equivalent relevant academic or vocational qualification
  • At least one year of oncology monitoring experience, or at least two years of standard monitoring experience plus relevant clinical experience such as physician, registered nurse, or study coordinator work
  • Proven clinical monitoring capability
  • Knowledge of the relevant medical or therapeutic area and medical terminology
  • Practical application of ICH GCP, applicable regulations, and procedural documentation
  • Strong critical-thinking, root-cause-analysis, and problem-solving abilities
  • Ability to apply risk-based monitoring principles and processes
  • Clear written and verbal communication with medical professionals
  • Customer focus, active listening, and strong attention to detail
  • Effective interpersonal, organizational, and time-management skills
  • Adaptable and flexible approach to changing needs
  • Capacity to work independently and collaboratively
  • Microsoft Office proficiency and the ability to learn required software
  • Strong English language and grammar skills
  • Effective presentation capability
  • Ability to meet sponsor, client, and site requirements, including disclosure of vaccination status or other personal information
  • Willingness and ability to travel frequently, typically 60–80%, including regular drives to study sites and occasional extended overnight stays
  • Ability to work in office, laboratory, clinical, and home-office settings
  • Ability to use required personal protective equipment, including protective eyewear, garments, and gloves

Benefits

  • Fully remote work arrangement
  • Standard Monday–Friday schedule

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