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

3+ years

Not Disclosed

Remote

10 Oct. 28, 2025

Job Description

Job Type: Full Time Remote 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

🌍 Job Title: Clinical Research Associate II (Home-Based, Delhi)

🏢 Company: Syneos Health®

📍 Location: Remote – Delhi, India

🆔 Job ID: 25102675

🗓️ Updated On: October 24, 2025

💉 Therapeutic Area: Cardiovascular Disease (CVD) experience preferred

🔬 About Syneos Health

Syneos Health® is a global, fully integrated biopharmaceutical solutions organization built to accelerate customer success.
We combine clinical, medical affairs, and commercial expertise to translate insights into real-world outcomes — because work here matters everywhere.

With over 29,000 employees across 110 countries, we bring patients and customers to the center of everything we do, simplifying processes and delivering better results for our partners.

🌐 Learn more: www.syneoshealth.com

💼 Position Overview

As a Clinical Research Associate II (CRA II), you will be responsible for the oversight and monitoring of clinical trial progress to ensure it is conducted, recorded, and reported in accordance with GCP, SOPs, protocols, and regulatory requirements.
This home-based role involves close collaboration with clinical sites, ensuring quality, compliance, and patient safety across assigned studies — particularly within Cardiovascular Disease (CVD) trials.

🎯 Key Responsibilities

🔎 Study Monitoring & Oversight

Conduct on-site and remote monitoring visits (pre-study, initiation, routine, and close-out).
Ensure site compliance with study protocols, ICH-GCP, and regulatory guidelines.
Verify that data entered in eCRFs is accurate, complete, and consistent with source documents.
Evaluate investigator site performance and adherence to timelines and recruitment targets.
Identify, document, and escalate protocol deviations and quality issues as needed.
Perform unblinded site monitoring when required, maintaining study integrity.

🤝 Site Management & Communication

Serve as primary point of contact for investigators and site personnel.
Develop and maintain strong relationships with clinical sites and cross-functional teams.
Provide training and guidance to site staff to ensure readiness and compliance.
Motivate sites to achieve enrolment and retention goals, resolving challenges proactively.
Manage multiple protocols across therapeutic areas with flexibility and prioritization.

🗂️ Regulatory & Documentation

Assist with Ethics Committee submissions, ICF reviews, and document collection.
Ensure timely access to eDC, vendor systems, and required trial tools.
Prepare study initiation materials and support database lock activities.
Contribute to audit preparation, inspection readiness, and CAPA documentation.

📚 Qualifications

🎓 Education

Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field (mandatory).
Master’s degree in Pharmacy/Life Sciences preferred.

💼 Experience

Minimum 3+ years of clinical research experience with at least 1 year of on-site monitoring (3–4 years preferred).
Prior experience with Cardiovascular (CVD) or related therapeutic areas preferred.
Familiarity with pharma/biotech sponsors or experience as a clinical study coordinator is a plus.

⚙️ Technical Skills

Solid understanding of ICH-GCP guidelines and local regulatory requirements.
Strong working knowledge of clinical research processes and documentation flow.
Proficiency in CTMS, eTMF, and EDC systems.
Excellent organization, time management, and data interpretation skills.
Proficient in Microsoft Office and adaptable to new technologies.

💡 Key Competencies

Excellent communication and presentation skills.
Ability to work independently and make data-driven decisions.
Skilled at problem-solving and risk assessment in clinical environments.
Strong relationship-building with sites and cross-functional teams.
Willingness to travel up to 75%, based on project and site requirements.

🌟 Why Join Syneos Health

At Syneos Health, you’ll find:

🚀 Career development and progression opportunities
👩‍🏫 Supportive and engaged line management
🧠 Continuous learning in therapeutic areas and technology
🏆 Recognition and rewards programs
💬 A culture of authenticity through our Total Self philosophy, where everyone belongs and thrives.

📊 Summary

Roles within Clinical Monitoring (CRA) are crucial to ensuring the integrity and quality of clinical research.
You will:

Oversee data and process integrity remotely and on-site.
Ensure compliance with global and local regulatory standards.
Collaborate with clinical teams to enhance trial quality and patient safety.
Use risk-based monitoring and data analytics to drive proactive decision-making.

You’ll be part of a global organization that, in the past five years, has supported:
✅ 94% of all FDA-approved novel drugs
✅ 95% of EMA-authorized products
✅ 200+ studies across 73,000 sites and 675,000+ patients

⚖️ Equal Opportunity Statement

Syneos Health is committed to building a diverse, inclusive, and authentic workplace.
We welcome applicants from all backgrounds, including those with transferable skills from other industries.

Join our Talent Network to stay informed about future opportunities.

🚀 Join Us

Be part of a company that’s changing the future of medicine — where every role matters and every career makes an impact.

🔗 Apply Now | or Join Our Talent Network to explore future opportunities.

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

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