Clinical Research Associate II (CRA II) – Delhi & Bangalore
Location: Delhi and Bangalore, India
Job ID: 25104059
Updated: December 3, 2025
Company: Syneos Health
About the Role
Syneos Health is a global, fully integrated biopharmaceutical solutions organization committed to accelerating clinical development. As a Clinical Research Associate II (CRA II), you will play a critical role in ensuring the integrity, accuracy, and compliance of clinical trial activities across assigned sites in Delhi and Bangalore.
This position requires in-depth knowledge of ICH-GCP guidelines, regulatory requirements, and strong on-site and remote monitoring capabilities. You will support site qualification, initiation, monitoring, and close-out activities while collaborating closely with clinical teams and sponsor representatives.
Key Responsibilities
Clinical Monitoring & Site Management
Conduct site qualification, initiation, interim monitoring, and close-out visits (onsite and remote) in compliance with protocol, ICH-GCP, SOPs, and regulatory guidelines.
Evaluate site performance, identify non-compliance issues, escalate risks, and recommend corrective actions.
Ensure informed consent procedures are properly conducted and documented for every study participant.
Assess site practices, source documents, and CRFs for accuracy, completeness, and data quality.
Manage site-level data queries and drive timely resolution.
Data Verification & Documentation
Review medical records and verify clinical data for completeness and accuracy.
Ensure electronic data capture requirements are followed at each site.
Maintain accurate study documentation including follow-up letters, trip reports, and communication logs.
Investigational Product Oversight
Review IP storage, accountability, reconciliation, and dispensing to ensure compliance with protocol and regulatory standards.
Monitor randomization/blinding processes and identify risks related to IP handling.
Regulatory and Site File Compliance
Review Investigator Site Files (ISF) and reconcile with the Trial Master File (TMF).
Ensure essential documents are archived according to local regulations.
Cross-Functional Collaboration
Serve as a primary liaison for site personnel, sponsor teams, and central monitoring associates.
Support subject recruitment and patient retention strategies.
Participate in investigator meetings, global CRA meetings, and project-specific training.
Audit & Inspection Readiness
Guide site teams to maintain high audit-readiness standards.
Support audit preparation and follow-up activities.
Real World Evidence (RWE) Support (if applicable)
Perform chart abstraction and real-world data collection.
Collaborate with medical science liaisons and local affiliates.
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Nursing (RN), or related field; or equivalent education and clinical research experience.
Strong knowledge of ICH-GCP, local regulatory requirements, and clinical research processes.
Proficiency in clinical monitoring tools, electronic systems, and data review methodologies.
Excellent interpersonal, communication, and presentation skills.
Ability to travel up to 75% regularly for site visits.
Strong documentation accuracy and time management skills.
Experience Required
Minimum 2 to 4 years of independent monitoring experience as a CRA in clinical research.
Proven experience in Phase II–IV trials preferred.
Prior exposure to risk-based monitoring and remote monitoring tools is an advantage.
Experience working with cross-functional teams and external stakeholders.
Why Join Syneos Health
Global exposure across 110+ countries and involvement in leading FDA-approved and EMA-authorized product research.
Opportunities for continuous learning, professional development, and structured career progression.
Inclusive and supportive work environment with a strong focus on employee well-being and performance.
Position Summary
The CRA II role involves full oversight of clinical trial site activities, ensuring data integrity, regulatory compliance, and adherence to protocol standards. You will contribute significantly to the quality and operational success of clinical trials by applying advanced monitoring skills, problem-solving abilities, and clinical research knowledge.
How to Apply
Interested candidates can apply directly through ThePharmaDaily.com job portal.
If this position is not currently open, your application will be added to the talent pipeline for future opportunities.
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