Clinical Research Associate II (CRA II) – Home-Based (Delhi)
Company: Syneos Health
Updated: 24-Oct-2025
Location: Remote – Delhi, India
Job ID: 25102675
About Syneos Health
Syneos Health is a global, fully integrated biopharmaceutical solutions organization, helping accelerate clinical, medical affairs, and commercial outcomes.
29,000 employees across 110 countries
Supported 94% of FDA-approved drugs (last 5 years)
Supported 95% of EMA-authorized products
Worked on 200+ studies, 73,000 sites, 6.75 lakh patients
WORK HERE MATTERS EVERYWHERE
Position Summary
The CRA II oversees the progress, quality, safety, and compliance of clinical trial sites.
Responsible for monitoring, risk assessment, site management, and ensuring adherence to protocol, SOPs, ICH-GCP, and regulatory requirements.
Role involves remote + onsite monitoring, heavy site communication, and travel up to 75%.
CVD (Cardiovascular Disease) experience preferred.
Minimum Qualifications
Bachelor’s degree in Life Sciences (Master’s in Pharmacy/Life Sciences preferred)
3+ years clinical research experience
Minimum 1 year monitoring experience (3–4 years preferred)
Understanding of ICH-GCP and local regulatory requirements
Ability to work independently
Strong communication and interpersonal skills
Good computer skills & ability to learn new systems
Must-Have Skills
Solid knowledge of ICH/GCP, local health authority regulations
Experience in drug development process
Understanding of clinical research processes & methodologies
Familiarity with:
Medical settings
Medical records management
Strong time management and organisation
Ability to build and maintain site relationships under pressure
Preferred Skills
Prior experience in:
Pharma/Biotech Sponsor environment
Clinical Study Coordinator roles
3+ years monitoring experience (highly preferred)
General Role Description
Responsible for:
Overseeing clinical trial site activities
Ensuring protocol and regulatory compliance
Monitoring data accuracy, safety reports, and subject protection
Acting as a key point of contact between study sponsors, CRO, and sites
Key Responsibilities and Duties
✅ 1. Site Selection & Feasibility
Identify new potential investigators
Assess site capabilities and resource availability
Recommend qualified sites for selection
Conduct pre-study visits
✅ 2. Site Initiation & Training
Conduct initiation visits
Ensure site staff receives protocol-specific training
Support preparation of Study Initiation Visit materials
✅ 3. Monitoring & Site Management
Perform on-site and remote monitoring visits
Ensure subject safety and data quality
Verify eCRF data accuracy
Conduct Unblinded Site Monitor activities when needed
Assess risks, identify issues, and make decisions based on data
Oversee site personnel (without direct authority)
Motivate sites to meet enrollment & retention goals
✅ 4. Issue Resolution & Escalation
Identify and proactively resolve site issues
Document findings and escalate serious issues
Recommend and track corrective and preventive actions (CAPA)
Support regulatory audits and inspections
✅ 5. Site Communication & Coordination
Serve as primary site contact
Provide ongoing training to site staff
Manage multiple protocols across multiple therapeutic areas
Liaise with CRO partners and vendors
✅ 6. Study Closure
Conduct site closure visits
Ensure all follow-up activities and documentation are complete
Support database lock timelines
✅ 7. Additional Support (As Needed)
Support Ethics Committee submissions & ICF review
Assist with equipment calibration and tracking
Ensure site access to eDC and vendor systems
Collect/send essential documents to/from site
Qualification Summary
Bachelor’s or Master’s in Life Sciences/Pharmacy
Strong knowledge of ICH-GCP
Excellent communication & presentation skills
Ability to travel up to 75%
Strong analytical and interpersonal abilities
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