Clinical Research Associate II (Home-Based, Delhi)
Therapeutic Area: Cardiovascular Disease (CVD) – Experience Preferred
Updated: October 24, 2025
Location: India (Remote – Client-Based)
Job ID: 25102675
Company: Syneos Health®
About the Company
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization that partners with clients to accelerate clinical, medical, and commercial success.
With operations in 110 countries and over 29,000 employees, the company’s model places patients and customers at the center of every initiative.
Motto: “Work Here Matters Everywhere.”
Why Work at Syneos Health
Strong focus on career development and internal growth.
Supportive leadership and structured technical/therapeutic training.
Commitment to diversity, inclusion, and authenticity through the Total Self Culture.
Recognition programs and competitive total rewards package.
A collaborative environment that values innovation and excellence.
Position Overview
The Clinical Research Associate II (CRA II) is responsible for monitoring the progress of clinical trials, ensuring compliance with protocols, SOPs, GCP, and regulatory requirements.
The role involves on-site and remote monitoring, maintaining site relationships, ensuring data integrity, and supporting the delivery of high-quality clinical studies.
Key Responsibilities
1. Site Identification & Feasibility
Identify and assess new potential investigators and research sites.
Evaluate site resources and capabilities for conducting trials.
Recommend qualified sites during feasibility and selection.
2. Study Initiation & Training
Conduct pre-study and initiation visits.
Provide protocol-specific and GCP training to investigators and site personnel.
Ensure sites are prepared for activation.
3. Monitoring & Oversight
Conduct on-site and off-site monitoring visits.
Verify data accuracy, protocol adherence, and subject safety.
Perform Unblinded Site Monitor activities as needed.
Use data analytics to assess risks and identify site issues.
4. Site Management
Serve as the main point of contact for study sites.
Motivate sites to meet recruitment and retention goals.
Review eCRFs and ensure data completeness and quality.
Track CAPAs (Corrective and Preventive Actions) to resolution.
5. Audit & Compliance
Support regulatory audits and inspections.
Assist in the preparation of site CAPA plans.
Ensure adherence to ICH-GCP, local laws, and sponsor standards.
6. Documentation & Reporting
Prepare and submit monitoring and administrative reports.
Ensure proper documentation of findings, issues, and corrective actions.
May assist with EC submissions, ICF reviews, and study close-out documentation.
7. Additional Responsibilities
Support study initiation material preparation.
Ensure access to eDC/client systems for site personnel.
May assist with equipment tracking and database lock activities.
Required Qualifications
Education:
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field (required).
Master’s degree in Pharmacy/Life Sciences (preferred).
Experience:
Minimum 3+ years of clinical research experience.
At least 1 year of independent monitoring experience (3–4 years preferred).
Prior experience in Cardiovascular (CVD) studies advantageous.
Technical Knowledge:
Strong understanding of ICH-GCP, regulatory guidelines, and clinical trial processes.
Experience with eCRF and clinical trial management systems.
Proficiency with data-driven monitoring and issue escalation.
Core Skills & Competencies
Strong communication and interpersonal skills.
Excellent organization and time management.
Ability to build and maintain site relationships under pressure.
Sound problem-solving and decision-making capabilities.
Proficiency in MS Office and digital platforms.
Ability to manage up to 75% travel as required.
Preferred Background
Prior experience in Pharma/Biotech sponsor environment or as a Clinical Study Coordinator.
Experience in risk-based monitoring and CVD therapeutic area.
Familiarity with regulatory audits and inspections.
Summary of Role Impact
CRAs are responsible for ensuring data quality, subject safety, and regulatory compliance in clinical trials.
They play a vital role in bridging site operations, sponsor requirements, and patient safety to ensure trial success.
About Syneos Health
Partnered in 94% of FDA-approved and 95% of EMA-authorized products over the past 5 years.
Conducted over 200 studies across 73,000 sites and 675,000+ patients globally.
Recognized for clinical innovation, collaboration, and scientific excellence.
🌐 Learn more: www.syneoshealth.com
Equal Opportunity Statement
Syneos Health is an Equal Opportunity Employer, committed to diversity and inclusion.
Applicants will receive consideration without regard to race, color, gender, age, disability, or other protected characteristics.
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