Clinical Research Associate (CRA) / Senior Clinical Research Associate (Senior CRA)
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Experience Required: 3–4 Years
Industry: Clinical Research | Clinical Operations | Medical Devices | CRO | Pharma | Biotechnology
About the Role
We are hiring a highly skilled and execution-driven Clinical Research Associate (CRA) / Senior CRA for a dynamic clinical research environment focused on operational excellence, regulatory compliance, and high-quality clinical trial execution.
This opportunity is ideal for professionals with strong expertise in site monitoring, source data verification (SDV), GCP compliance, audit readiness, and clinical trial management. The selected candidate will play a critical role in ensuring studies are conducted according to approved protocols, regulatory requirements, and global quality standards.
If you are passionate about maintaining clean, inspection-ready data and managing clinical sites independently, this role offers excellent exposure to advanced clinical operations and data quality management practices.
Key Responsibilities
1. Clinical Site Monitoring & Study Execution
Independently manage assigned clinical trial sites from Site Initiation Visit (SIV) to Close-Out Visit (COV)
Conduct routine monitoring visits as per study timelines and monitoring plans
Oversee patient recruitment activities, eligibility verification, informed consent documentation, and subject follow-up compliance
Ensure strict adherence to:
Good Clinical Practice (GCP)
ICH Guidelines
ISO 14155 Standards
Study Protocols & SOPs
Identify protocol deviations, compliance risks, and operational gaps proactively and implement corrective actions
Train and guide site coordinators, investigators, and junior clinical staff on protocol procedures, EDC systems, and regulatory compliance
Coordinate effectively with sponsors, CROs, investigators, data management teams, and cross-functional stakeholders
2. Source Data Verification (SDV) & Clinical Data Quality Management
Perform rigorous Source Data Verification (SDV) and Source Data Review (SDR) activities
Ensure data accuracy, completeness, consistency, and timely documentation
Manage site-level query generation, follow-up, reconciliation, and closure
Maintain accurate source-to-EDC traceability and contemporaneous documentation practices
Support database lock activities through efficient site cleanup and documentation review
Contribute to improved operational efficiency through CRF design support and automated quality-check implementation
3. CAPA, Deviations & Safety Reporting
Accurately document:
Protocol deviations
Non-compliance events
Adverse Events (AEs)
Serious Adverse Events (SAEs)
Support implementation and effectiveness verification of Corrective and Preventive Actions (CAPAs)
Resolve site-level operational issues independently whenever possible and escalate critical concerns appropriately
4. Audit & Inspection Readiness
Maintain assigned sites in a constant state of inspection readiness
Support:
Internal Quality Audits
Sponsor Audits
Regulatory Inspections
Ensure complete, accurate, and audit-ready Trial Master File (TMF) documentation
Assist with regulatory submissions, IEC/IRB correspondence, and compliance documentation
5. Clinical Operations Collaboration & Scientific Support
Collaborate closely with Clinical Operations and Data Quality leadership teams on:
Site performance
Study timelines
Risk mitigation strategies
Support database lock preparation and clinical data reconciliation activities
Contribute to:
Protocol development
Scientific manuscript drafting
Journal submission activities
Abstract preparation and statistical reporting
Utilize tools such as Python and SPSS for workflow automation, statistical analysis, and data validation support
Required Qualifications
Mandatory Skills & Experience
3–4 years of experience as a Clinical Research Associate (CRA)
Strong hands-on experience in:
Clinical site monitoring
SDV/SDR activities
Query management
Clinical trial documentation
Excellent understanding of:
GCP
ICH Guidelines
ISO 14155
Experience working with Electronic Data Capture (EDC) systems
Ability to independently manage multiple clinical sites simultaneously
Strong communication, documentation, and stakeholder management skills
Preferred Qualifications
Experience in medical device clinical trials
Exposure to sponsor audits and regulatory inspections
Experience supporting database lock and reconciliation activities
Knowledge of statistical analysis and clinical data validation tools
Scientific writing and publication support experience
Desired Candidate Profile
We are looking for professionals who are:
Highly detail-oriented and quality-focused
Strong in execution and operational ownership
Committed to maintaining audit-ready clinical documentation
Proactive problem-solvers in real-world clinical settings
Comfortable working independently in fast-paced clinical research environments
Passionate about improving data integrity and patient safety
Why Apply?
Opportunity to work on high-impact clinical research projects
Exposure to advanced clinical operations and regulatory practices
Collaborative and quality-focused work environment
Strong career growth opportunities in Clinical Research & Clinical Operations
Hands-on involvement in end-to-end trial execution and compliance management
Apply Now
Professionals with experience in Clinical Research, Site Monitoring, GCP Compliance, Medical Device Trials, Clinical Data Quality, SDV, EDC Management, and Regulatory Documentation are encouraged to apply.
Explore more global Clinical Research and Pharmacovigilance opportunities on ThePharmaDaily.
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