Clinical Research Associate II (CRA II)
Location: Bangalore
Experience: 2–5+ Years
Department: Clinical Operations / Clinical Monitoring
Industry: CRO / Pharmaceutical / Biotechnology / Medical Devices
Job Summary
The Clinical Research Associate II (CRA II) is responsible for managing and monitoring clinical trial sites to ensure compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and sponsor expectations. The role involves conducting site visits, verifying clinical data accuracy, ensuring patient safety, managing investigational products, and supporting overall study execution from initiation through close-out.
Key Responsibilities
Clinical Site Monitoring
Conduct Pre-Study Visits (PSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), Routine Monitoring Visits (RMV), and Close-Out Visits (COV).
Independently monitor assigned clinical trial sites according to study protocols, monitoring plans, SOPs, and ICH-GCP guidelines.
Evaluate site performance and ensure compliance with study requirements.
Verify that site personnel are appropriately trained and qualified to conduct study activities.
Patient Safety & Regulatory Compliance
Ensure proper informed consent procedures are followed and documented.
Verify subject eligibility and protocol compliance.
Monitor patient safety throughout the study lifecycle.
Ensure compliance with ICH-GCP, local regulatory requirements, sponsor guidelines, and study protocols.
Support audit and inspection readiness at investigator sites.
Source Data Verification & Data Review
Perform Source Document Verification (SDV) and Source Data Review (SDR).
Review eCRFs for completeness, accuracy, and consistency.
Identify missing, inconsistent, or implausible data.
Generate, track, and resolve data queries in collaboration with sites and data management teams.
Ensure data integrity and quality throughout the study.
Investigational Product (IP) Management
Verify Investigational Product accountability and inventory.
Review storage conditions, dispensing records, and reconciliation activities.
Ensure IP handling complies with protocol and regulatory requirements.
Track study supplies and shipments as required.
Site Documentation Management
Review and maintain Investigator Site Files (ISF).
Ensure site regulatory documentation remains current and complete.
Verify essential documents are filed appropriately in eTMF and sponsor systems.
Maintain audit-ready documentation throughout the study.
Safety Reporting
Support Serious Adverse Event (SAE) reporting processes.
Follow up on safety events and ensure timely documentation.
Collaborate with pharmacovigilance and safety teams when necessary.
Study Coordination & Project Support
Develop and implement study-specific monitoring plans.
Participate in investigator meetings, project meetings, and study teleconferences.
Present study training and site initiation materials.
Support study timelines and ensure delivery of project milestones.
Act as Lead CRA on assigned projects when required.
Reporting & Documentation
Prepare and submit monitoring visit reports within required timelines.
Document findings, deviations, and corrective actions.
Maintain accurate study records and monitoring documentation.
Required Qualifications
Education
Bachelor's Degree in:
Life Sciences
Pharmacy
Biotechnology
Nursing
Medical Laboratory Technology
Allied Health Sciences
OR
Equivalent clinical research experience.
Required Experience
Mandatory
Minimum 2 years of Clinical Monitoring experience as a CRA.
Experience independently conducting monitoring visits.
Experience with clinical trial site management.
Understanding of SAE reporting processes.
Preferred
Additional experience in:
Clinical Operations
Data Management
Medical Writing
Research Coordination
Laboratory Research
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