Clinical Research Associate II (Client-Based, Mumbai Location)
Job ID: 25102785
Updated: November 4, 2025
Location: Pune, Maharashtra, India
Company: Syneos Health®
Job Type: Full-time
About Syneos Health
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success through clinical, medical, and commercial expertise.
Our unique model brings customers and patients to the center of everything we do. We continuously seek ways to simplify and streamline our processes to make Syneos Health both easier to work with and easier to work for.
With 29,000 employees across 110 countries, we are passionate about transforming lives through science.
WORK HERE MATTERS EVERYWHERE.
Why Join Syneos Health
Strong focus on career development and progression
Supportive and engaged line management
Continuous technical and therapeutic area training
Peer recognition and total rewards programs
Inclusive Total Self Culture promoting authenticity and belonging
Global, diverse, and collaborative work environment
Role Overview
The Clinical Research Associate II (CRA II) is responsible for monitoring clinical trials, ensuring compliance with protocols, SOPs, GCP, and regulatory requirements.
The CRA acts as the main point of contact at assigned sites, ensuring study integrity, patient safety, and data accuracy while collaborating with investigators and internal teams.
Key Responsibilities
Site Management & Oversight
Monitor and oversee the progress of clinical trials at assigned sites.
Ensure studies are conducted, recorded, and reported per ICH-GCP, SOPs, and regulatory guidelines.
Serve as primary contact for site-related communications.
Identify and assess new potential investigators and evaluate site capabilities.
Recommend sites for selection and conduct pre-study and initiation visits.
Train site staff on protocol requirements before site activation.
Monitoring & Compliance
Conduct on-site and remote monitoring visits to review study activities and data quality.
Ensure subject safety, protocol adherence, and data accuracy.
Perform unblinded monitoring when required to protect study blind integrity.
Utilize risk-based monitoring techniques to identify issues and trends.
Ensure timely eCRF data entry, query resolution, and source document verification.
Issue Resolution & Communication
Serve as liaison between the study sponsor, CRO, and site teams.
Identify, document, and escalate critical issues or deviations.
Propose and follow up on corrective/preventive actions (CAPA).
Support regulatory and compliance audits at site level.
Foster strong site relationships to ensure timely enrolment and retention.
Documentation & Reporting
Prepare monitoring visit reports accurately and promptly.
Support submission of Ethics Committee documents, ICF reviews, and archival activities.
Ensure site documentation and system access (e.g., eDC, vendor portals) are properly maintained.
Participate in study closure activities and ensure documentation completeness.
Cross-Functional Collaboration
Coordinate with global teams for consistent study execution.
Support study-level activities such as equipment tracking, database lock readiness, and training coordination.
Qualifications
Essential
Bachelor’s degree (preferably in Life Sciences or related field)
3+ years of clinical research experience, including at least 1 year of monitoring experience
Strong knowledge of ICH-GCP guidelines, local regulations, and clinical trial processes
Familiarity with drug development and medical record management
Excellent organization, time management, and relationship-building skills
Strong written and verbal communication abilities
Preferred
Prior experience with Pharma/Biotech Sponsors or as a Clinical Study Coordinator
3+ years of direct monitoring experience
Core Competencies
Knowledge of global and local regulatory frameworks
High proficiency in clinical data systems and MS Office Suite
Ability to manage multiple studies across therapeutic areas
Adaptability and problem-solving in complex study environments
Effective communication across cross-functional and multicultural teams
Willingness to travel up to 75% as per site or regional requirements
Impact & Contribution
As part of the Clinical Monitoring/CRA family, the CRA II ensures the integrity, quality, and compliance of clinical studies through risk-based and data-driven monitoring.
The role contributes by:
Overseeing site activities to maintain study compliance and patient safety
Supporting process optimization and data reliability
Driving timely completion of study milestones
Facilitating collaborative engagement between sites, sponsors, and internal stakeholders
The CRA II is a key individual contributor with technical expertise, practical judgment, and the ability to manage projects or defined study components independently.
About Syneos Health’s Global Impact
Partnered in 94% of all FDA-approved novel drugs over the past 5 years
Supported 95% of EMA-authorized products
Conducted 200+ studies across 73,000 sites and 675,000+ patients worldwide
Learn more at 👉 www.syneoshealth.com
Additional Information
Duties and responsibilities may evolve based on project needs.
Equivalent education or experience may be considered for qualification requirements.
This description does not constitute an employment contract.
Syneos Health ensures compliance with Equal Opportunity and Disability Accommodation regulations (including ADA).
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