Clinical Research Associate Ii (Home-Based, Delhi). Cvd Experience Preferred

Syneos Health

3+ years

Not Disclosed

India

10 Nov. 5, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Clinical Research Associate II (Home-based, Delhi) – CVD Experience Preferred

Updated: October 24, 2025
Location: IND – Client (Remote/Home-based)
Job ID: 25102675
Company: Syneos Health®

About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by combining clinical, medical, and commercial expertise.

With 29,000+ employees across 110 countries, the company partners with clients to deliver innovative, patient-focused solutions. Syneos Health continually simplifies and improves processes, making it easier to work with — and work for.

Work Here Matters Everywhere.

Why Join Us

Career development, progression, and training opportunities.
Supportive and engaged line management.
Peer recognition and total rewards program.
Inclusive Total Self culture — empowering employees to be their authentic selves.
Commitment to diversity, belonging, and global collaboration.

Position Overview

The Clinical Research Associate II (CRA II) oversees clinical trials to ensure they are conducted, recorded, and reported per protocols, SOPs, ICH-GCP, and regulatory requirements.
This role serves as a key liaison between sites, sponsors, and internal teams, focusing on data quality, site relationships, and subject safety.

Educational Qualifications

Bachelor’s degree in Life Sciences or equivalent field.
Master’s degree in Pharmacy/Life Sciences preferred.
Equivalent education, training, or experience combinations will be considered.

Experience Requirements

3+ years of relevant clinical research experience.
Minimum 1 year of independent monitoring experience required.
3–4 years of onsite monitoring experience preferred.
Prior experience with Pharma/Biotech sponsors or as a Clinical Study Coordinator preferred.

Core Competencies (Must-Have)

Sound knowledge of ICH-GCP guidelines and local regulatory requirements.
Understanding of the drug development process and clinical research methodology.
Strong organizational and time management abilities.
Effective relationship-building, even under pressure.
Competent in medical records management and site documentation.
Ability to work independently with minimal supervision.

Preferred Skills

Prior experience with cardiovascular disease (CVD) studies.
Familiarity with risk-based monitoring and eClinical systems (e.g., EDC, CTMS).
Exposure to regulatory submissions and Ethics Committee coordination.

Key Responsibilities

Ensure clinical trials are conducted in compliance with protocol, GCP, SOPs, and local regulations.
Identify and evaluate potential investigators and study sites.
Conduct feasibility assessments, pre-study, and site initiation visits.
Provide protocol-specific training to site staff.
Perform on-site and remote monitoring activities.
Oversee data accuracy, completeness, and timeliness in eCRF systems.
Build and maintain strong relationships with site staff and investigators.
Identify, escalate, and resolve site issues proactively; document corrective actions.
Participate in audit/inspection readiness and CAPA implementation.
Conduct site closure visits post-study completion.
Support preparation of study initiation materials and database lock activities.
May assist with:
- Ethics Committee submissions and document collection.
- Equipment calibration and tracking.
- Regulatory authority inspections and compliance audits.

Technical & Interpersonal Skills

Proficiency in Microsoft Office Suite and eClinical technologies.
Excellent communication, presentation, and interpersonal skills.
Strong analytical and problem-solving capabilities.
Willingness to travel up to 75% regularly.

Additional Information

Job responsibilities listed are not exhaustive. Syneos Health reserves the right to modify duties as required.
Equivalent experience and skills will be considered for qualification.
The company complies with ADA and offers reasonable accommodations for employees and applicants.
Syneos Health is committed to equal opportunity employment and global diversity initiatives.

Summary

Roles within Clinical Monitoring/CRA ensure the integrity and compliance of clinical research through site monitoring and data validation.
CRAs use risk-based monitoring approaches and data insights to maintain study quality, collaborate with site teams, and drive project success.

Type: Established, experienced individual contributor.
Focus: Clinical operations, monitoring, and compliance management.

About Syneos Health (Quick Facts)

Partnered on 94% of FDA-approved novel drugs in the past 5 years.
Supported 95% of EMA-authorized products.
Conducted 200+ studies across 73,000 sites and 675,000+ trial participants.

🔗 Learn More: www.syneoshealth.com
🌐 Join Talent Network: Stay connected with Syneos Health career opportunities.

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Clinical Research Associate Ii (Home-Based, Delhi). Cvd Experience Preferred

Job Description

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