Clinical Research Associate II (Home-based, Delhi) – CVD Experience Preferred
Company: Syneos Health®
Location: IND – Client (Home-based, Delhi preferred)
Job ID: 25102675
Updated: October 24, 2025
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We combine clinical, medical affairs, and commercial insights to drive real-world impact across 110 countries with a workforce of over 29,000 professionals.
Our mission is to bring patients and customers to the center of everything we do by simplifying processes, fostering collaboration, and advancing therapies that change lives.
Key Highlights:
94% of all novel FDA-approved drugs supported in the last 5 years
95% of EMA-authorized products managed
200+ studies conducted across 73,000 sites with 675,000+ trial patients
Our Culture:
“Total Self” culture promoting authenticity, inclusivity, and well-being
Continuous career growth through mentorship, technical training, and global exposure
Reward and recognition programs celebrating individual and team excellence
Position Overview
The Clinical Research Associate II (CRA II) is responsible for monitoring and overseeing clinical trial progress to ensure quality, integrity, and compliance with GCP, SOPs, and regulatory requirements. The role involves site management, data validation, and stakeholder communication to support successful trial delivery — with a preferred focus on cardiovascular disease (CVD) studies.
Key Responsibilities
Site Management & Oversight
Identify and assess potential investigators and clinical sites for feasibility.
Conduct pre-study, initiation, interim, and close-out visits.
Monitor clinical trial activities to ensure compliance with study protocol, ICH-GCP, and applicable regulations.
Ensure data accuracy and timely eCRF completion through centralized and on-site monitoring.
Perform unblinded site monitoring as required while maintaining study blind integrity.
Stakeholder & Relationship Management
Act as the primary point of contact for assigned sites.
Build and maintain strong site relationships to ensure engagement and protocol adherence.
Provide site personnel training on protocol, systems, and study processes.
Motivate and support sites in meeting enrollment and retention targets.
Quality & Compliance
Ensure trial documentation, reports, and records are accurate, timely, and audit-ready.
Support regulatory inspections and implement corrective/preventive actions (CAPA) when necessary.
Identify, document, and escalate site-level issues proactively.
Maintain adherence to monitoring plans and data integrity standards.
Operational & Administrative Support
Manage multiple studies across therapeutic areas as assigned.
Support Ethics Committee submissions and Informed Consent Form (ICF) reviews.
Coordinate study startup activities, equipment tracking, and site access to eDC/client systems.
Ensure timely database lock activities and submission of monitoring reports.
Qualifications
Education:
Bachelor’s degree in Life Sciences or equivalent (required)
Master’s degree in Pharmacy or Life Sciences (preferred)
RN or equivalent combination of education and clinical experience accepted
Experience:
Minimum 3+ years of relevant clinical research experience
At least 1 year of independent site monitoring required (3–4 years preferred)
Prior experience with Pharma/Biotech sponsors or Clinical Study Coordinator roles advantageous
CVD study experience preferred
Technical Skills:
Knowledge of ICH-GCP guidelines and applicable local regulations
Familiarity with clinical trial processes, regulatory frameworks, and documentation standards
Strong computer proficiency and adaptability to new technologies
Excellent written and verbal communication skills
Core Competencies:
Strong organizational and time-management abilities
Analytical problem-solving and risk assessment capability
Flexibility and adaptability in dynamic environments
Proven relationship-building and conflict-resolution skills
Travel Requirement: Up to 75% (as per study/site allocation)
Role Summary
The CRA II ensures the integrity of clinical research studies by monitoring processes, site compliance, and data accuracy. They apply risk-based monitoring techniques, data analytics, and regulatory knowledge to identify trends, mitigate risks, and maintain study quality.
This role contributes to the success of global trials through collaboration with site teams, implementation of quality systems, and adherence to ethical research standards.
Equal Opportunity & Compliance
Syneos Health is committed to diversity, equity, and inclusion. All qualified applicants will receive consideration regardless of race, color, religion, gender, age, disability, or veteran status.
Reasonable accommodations are available in compliance with the Americans with Disabilities Act (ADA) and applicable global legislation.
Learn more: www.syneoshealth.com
Position Type
Full-Time | Remote (Client-based) | Clinical Monitoring Division
Application Options:
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