Job Overview
Job Title: Clinical Research Associate / Senior CRA
Experience Required: 3–4 Years
Location: Bangalore
Employment Type: Full-Time
Role Summary
The Clinical Research Associate (CRA) / Senior CRA will be responsible for end-to-end site monitoring, clinical trial execution, and ensuring high-quality, audit-ready clinical data.
The role focuses on:
Site monitoring and oversight
Source data verification (SDV)
Compliance management
Audit readiness
Data quality assurance
Stakeholder collaboration
This position is ideal for professionals who take strong ownership of clinical operations and maintain high standards in trial execution and documentation.
Key Responsibilities
1. Site Execution & Monitoring (Primary Responsibility)
Manage assigned clinical trial sites from:
Site Initiation Visit (SIV)
Routine Monitoring Visits
Close-Out Visits (COV)
Oversee:
Patient recruitment
Eligibility verification
Informed consent processes
Follow-up compliance
Ensure compliance with:
GCP
ICH guidelines
ISO 14155 standards
Study protocols
Identify and resolve:
Protocol deviations
Non-compliance issues
Operational risks
Train and support:
Site staff
Junior coordinators
Users on EDC systems and protocol procedures
Coordinate with:
Sponsors
CROs
Investigators
Data management teams
2. Data Quality & Source Verification
Perform:
Source Data Verification (SDV)
Source Data Review (SDR)
Ensure:
Accuracy and completeness of data
Timely query resolution
Proper source-to-EDC traceability
Contemporaneous documentation
Support:
Database lock readiness
Site cleanup activities
Contribute to:
CRF design
Automated quality checks
Workflow improvements
3. Issue Management & CAPAs
Document:
Protocol deviations
Adverse Events (AEs)
Serious Adverse Events (SAEs)
Non-compliance events
Support:
Corrective and Preventive Actions (CAPAs)
CAPA implementation verification
Escalate issues only when necessary and proactively resolve site-level problems
4. Audit & Inspection Readiness
Maintain inspection-ready sites at all times
Support:
Internal audits
Sponsor audits
Regulatory inspections
Maintain accurate and complete:
Trial Master File (TMF)
Site documentation
5. Collaboration & Communication
Assist with:
Regulatory submissions
IEC/IRB communication
SAE reporting
TMF maintenance
Work closely with:
Clinical Operations teams
Data Quality Managers
Investigators
Site coordinators
Provide:
Timely monitoring reports
Follow-up actions and risk updates
Mandatory Requirements
Experience
3–4 years of experience as a Clinical Research Associate
Technical Expertise
Hands-on experience in:
Site monitoring
SDV activities
Query management
EDC systems
Regulatory Knowledge
Strong understanding of:
GCP
ICH Guidelines
ISO 14155
Operational Skills
Ability to independently manage multiple clinical sites
Preferred Qualifications
Industry Exposure
Experience in medical device clinical trials
Exposure to audits and regulatory inspections
Experience supporting database lock activities
Technical & Analytical Skills
Knowledge of:
Python
SPSS
Experience in:
Data validation
Statistical reporting
Workflow automation
Scientific & Research Contributions
Support for:
Abstract development
Scientific presentations
Statistical analysis reporting
Manuscript drafting
Journal submissions
Protocol development
Desired Mindset & Traits
Ownership Mentality
Strong accountability for:
Site performance
Data quality
Compliance standards
Execution Excellence
Detail-oriented and process-driven
High standards for documentation accuracy
Problem-Solving Ability
Comfortable resolving operational challenges in clinical settings
Proactive and solution-oriented approach
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Brazil | Sao paulo |Attica :
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Japan | Saitama |Tokyo :
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South Africa | Midrand |Nišava District :
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