Clinical Research Associate II (CRA II) – FSP Business Unit
Thermo Fisher Scientific · Remote
RoleLantern re-checked this role's application link recently and it was active — the employer has not confirmed it directly.
Role summary
Clinical Research Associate II position supporting pharmaceutical and biotech clinical trials across multiple countries. The role involves remote and on-site monitoring of investigational sites, ensuring protocol compliance, managing documentation, and coordinating with sponsors and sites to maintain data integrity and regulatory standards.
What they're looking for
- Bachelor's degree in life sciences or registered nursing certification
- Approximately one year clinical research monitoring experience or PPD fellowship completion
- Proficient in ICH-GCP guidelines, applicable regulations, and standard operating procedures
- Strong critical thinking, root cause analysis, and problem-solving abilities
- Excellent written and oral communication skills with medical personnel
- Risk-based monitoring knowledge and demonstrated organizational skills
- Valid driver's license where applicable
What you'll be doing
- Conduct remote and on-site site monitoring visits using risk-based approaches and root cause analysis
- Ensure protocol compliance, regulatory adherence, and ICH-GCP standards through document review and data verification
- Initiate and manage trial sites, identify qualified investigators, and conduct site closeout procedures
- Prepare monitoring reports, escalate deficiencies to management, and track issue resolution
- Facilitate communication between investigative sites, sponsors, and project teams; support regulatory audits and inspections
Privacy & handoff
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