Instagram
youtube
Facebook

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

0-2 years
Not Disclosed
10 Nov. 11, 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

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