Clinical Research Associate II (CRA II)
Company: Fortrea
Job Title: Clinical Research Associate II (CRA II)
Job ID: 262282
Location: Bengaluru, Karnataka
Job Category: Clinical Research / Clinical Operations
Employment Type: Full-time
Work Mode: Field-Based / Hybrid (Site Monitoring Role)
Travel Requirement: 60% Travel
Job Summary
Fortrea is hiring a Clinical Research Associate II (CRA II) to manage and monitor clinical trial sites, ensure regulatory compliance, protect patient safety, maintain data integrity, and oversee site operations according to ICH-GCP guidelines and sponsor requirements. This is an experienced clinical monitoring role with independent site management responsibilities.
Key Responsibilities
Manage assigned clinical trial sites independently.
Conduct site monitoring visits including:
Pre-Study Visits
Site Initiation Visits (SIV)
Routine Monitoring Visits
Process Monitoring Visits
Close-Out Visits
Ensure compliance with:
ICH-GCP guidelines
Sponsor protocols
Regulatory requirements
Fortrea SOPs
Verify informed consent compliance and patient safety protection.
Perform:
Source Document Verification (SDV)
eCRF review
Query generation & resolution
Data quality checks
Ensure study data accuracy, completeness, and consistency.
Maintain:
Regulatory documents
eTMF / Sponsor documentation
Investigational Product (IP) accountability
Track study supplies and IP shipments.
Monitor and follow up on Serious Adverse Events (SAEs).
Prepare trip reports and monitoring documentation.
Support investigator recruitment and site management activities.
Deliver site initiation training.
Participate in investigator meetings and project calls.
Support audit readiness and compliance inspections.
Assist in training junior team members.
Required Qualifications
University / College Degree in:
Life Sciences
Nursing
Allied Health Profession
Related Clinical Field
OR equivalent relevant experience
Required Experience
Minimum 2 years of Clinical Monitoring experience
Ability to independently monitor study sites
Experience with:
Clinical trial monitoring
SAE follow-up
Site management
Regulatory compliance
Monitoring plans execution
Required Skills
Technical Skills
Clinical Trial Monitoring
Site Management
ICH-GCP
Source Document Verification (SDV)
eCRF Review
Query Management
SAE Reporting
Regulatory Documentation
eTMF Management
CTMS / eClinical Systems
Investigational Product Accountability
Monitoring Plan Execution
Clinical Operations
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