Clinical Research Associate II (Home-based, Delhi)
Company: Syneos Health®
Location: IND – Remote (Delhi preferred)
Job ID: 25102675
Updated: October 24, 2025
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization with a mission to accelerate customer success. We combine clinical, medical affairs, and commercial expertise to improve patient outcomes and drive innovation across 110+ countries with over 29,000 employees.
Our Core Values:
Patient and customer-centered approach
Streamlined and collaborative working model
Continuous improvement and innovation
Diversity, inclusion, and authentic workplace culture
Why Work Here:
Career development and progression opportunities
Supportive and engaged management
Peer recognition and rewards
Inclusive “Total Self” culture that values individuality
Position Summary
The Clinical Research Associate II (CRA II) is responsible for monitoring the progress of clinical trials, ensuring compliance with study protocols, SOPs, GCP, and regulatory requirements. The CRA serves as a primary contact for site-level activities, ensuring quality, accuracy, and timely data collection.
Key Responsibilities
Site Management & Monitoring
Identify and assess new investigator sites and evaluate resources for trial feasibility.
Conduct pre-study, initiation, routine, and close-out visits.
Review and monitor clinical site activities both onsite and remotely.
Ensure safety and protection of study subjects in accordance with monitoring plans and ICH-GCP.
Ensure eCRF data accuracy and timely updates via relevant systems.
Perform unblinded monitoring when required, maintaining study blind integrity.
Oversee site personnel (without direct authority) to ensure adherence to protocol and study objectives.
Communication & Relationship Management
Build and maintain productive site relationships.
Act as the primary point of contact for assigned sites.
Provide training to site staff on protocol, procedures, and systems.
Proactively identify, document, and resolve issues; escalate persistent issues as needed.
Motivate sites to achieve enrollment and retention goals.
Quality & Compliance
Ensure trials are conducted per GCP, protocol, SOPs, and applicable regulations.
Support audit/inspection readiness and CAPA (Corrective and Preventive Actions) implementation.
Prepare accurate and timely monitoring and administrative reports.
Additional/Supportive Tasks
Support ethics committee submissions and ICF review.
Coordinate study startup materials and equipment calibration/tracking.
Ensure database lock timelines are achieved.
Qualifications
Education:
Bachelor’s degree in Life Sciences or related field required.
Master’s in Pharmacy/Life Sciences preferred.
Experience:
Minimum 3 years of clinical research experience.
At least 1 year of independent monitoring experience required (3–4 years preferred).
Prior experience in Pharma/Biotech or as a Clinical Study Coordinator advantageous.
Technical & Professional Skills:
Solid understanding of ICH-GCP guidelines and local regulatory requirements.
Knowledge of drug discovery/development and clinical trial methodologies.
Strong organization, prioritization, and time-management skills.
Excellent interpersonal and communication abilities.
Proficiency with clinical trial software systems and Microsoft Office Suite.
Willingness to travel up to 75% as required.
Preferred Competencies
Analytical mindset with ability to identify risks and implement solutions.
Effective collaborator capable of managing multiple protocols and therapeutic areas.
Adaptable communication style with cross-functional teams.
Experience in CVD (Cardiovascular Disease) studies preferred.
Summary of Impact
CRAs at Syneos Health play a key role in maintaining the integrity of clinical studies by ensuring regulatory compliance, quality data collection, and patient safety. They utilize risk-based and remote monitoring strategies to enhance clinical efficiency and support global study delivery.
About Syneos Health (Impact Overview)
Partnered with 94% of FDA-approved drugs and 95% of EMA-authorized products over the past five years.
Conducted 200+ studies across 73,000 sites with 675,000+ trial patients worldwide.
A global leader in clinical operations and integrated drug development.
Additional Information
The job description is not exhaustive and duties may evolve as per organizational requirements.
Syneos Health is an Equal Opportunity Employer committed to diversity and inclusion.
Reasonable accommodations will be provided in compliance with ADA and regional regulations.
Learn more: www.syneoshealth.com
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