Clinical Research Associate II (CRA II) – Oncology / Ophthalmology
Company: Thermo Fisher Scientific
Job Title: Clinical Research Associate II (CRA II)
Job ID: R-01351702
Location: Multiple Locations, USA (Remote)
Job Category: Clinical Research / Clinical Monitoring / Clinical Operations
Employment Type: Full-time
Work Mode: Fully Remote
Job Summary
Thermo Fisher Scientific (PPD Clinical Research Services) is hiring a Clinical Research Associate II (CRA II) to manage clinical trial monitoring and site management activities for Oncology and Ophthalmology studies. The role involves site monitoring, regulatory compliance, investigational product oversight, risk-based monitoring, and ensuring subject safety and data integrity.
Key Responsibilities
Clinical Monitoring & Site Management
Conduct:
On-site monitoring visits
Remote monitoring visits
Site initiation visits
Routine monitoring visits
Study close-out visits
Ensure compliance with:
Study protocol
ICH-GCP
Regulatory requirements
SOPs
Verify:
Source documents (SDR / SDV)
CRF accuracy
Data quality
Investigational product accountability
Risk-Based Monitoring
Apply Risk-Based Monitoring (RBM) methodologies.
Perform:
Root Cause Analysis (RCA)
CAPA follow-up
Issue escalation
Site compliance correction
Monitor site performance and risk indicators.
Regulatory & Documentation
Ensure essential documents are complete and inspection-ready.
Conduct site file reviews.
Maintain CTMS updates and monitoring documentation.
Support audit / inspection readiness.
Stakeholder Coordination
Communicate with:
Investigative sites
Clinical Team Managers
Sponsors / clients
Internal project teams
Support:
Investigator meetings
Site identification
Investigator payments
Trial material retrieval
Process improvement initiatives
Required Qualifications
Bachelor’s Degree in Life Sciences
OR
Registered Nursing certification
OR equivalent qualification
Valid driver’s license may be required.
Required Experience
Minimum 1+ year of clinical monitoring experience
OR
Completion of PPD Drug Development Fellowship
Experience in:
Clinical monitoring
Site management
Clinical trial operations
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