Clinical Research Associate (CRA II) – FSP Neuroscience
Company: Thermo Fisher Scientific
Job Title: Clinical Research Associate (CRA II) – FSP Neuroscience
Job ID: R-01346344
Location: Remote, Georgia, USA
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 (CRA II) – FSP Neuroscience to manage clinical trial monitoring, site management, regulatory compliance, and risk-based monitoring for neuroscience clinical studies. The role involves conducting remote and on-site monitoring visits while ensuring protocol compliance, patient safety, and data integrity.
Key Responsibilities
Clinical Monitoring & Site Management
Conduct:
Remote monitoring visits
On-site monitoring visits
Site initiation visits
Routine monitoring visits
Study close-out visits
Ensure compliance with:
Study protocol
ICH-GCP
Regulatory requirements
SOPs
Review:
Source documents (SDR / SDV)
CRFs
Site documentation
Investigational product accountability
Risk-Based Monitoring
Apply Risk-Based Monitoring (RBM) methodology.
Perform:
Root Cause Analysis (RCA)
CAPA follow-up
Site risk assessment
Issue escalation
Ensure site deficiencies are resolved promptly.
Study Coordination
Support:
Investigator meetings
Site identification
Site activation
Trial material retrieval
Investigator payment processes
Maintain CTMS updates and monitoring documentation.
Provide progress updates to Clinical Team Managers (CTM).
Support audit and inspection readiness.
Stakeholder Communication
Coordinate communication between:
Investigative sites
Sponsors / clients
Internal project teams
Clinical management
Support process improvement initiatives.
Required Qualifications
Bachelor’s Degree in Life Sciences
OR
Registered Nursing certification
OR equivalent relevant qualification
Additional requirement:
Valid driver’s license (where applicable)
Required Experience
Minimum 1+ year of clinical research monitoring experience
OR
Completion of PPD Drug Development Fellowship
Experience in:
Clinical monitoring
Site management
Clinical trial execution
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Remote, India | Siliguri |Illinois :
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