Clinical Research Associate Ii (Client Base, Mumbai Location)

3+ years

Not Disclosed

Pune

10 Nov. 6, 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 (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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Clinical Research Associate Ii (Client Base, Mumbai Location)

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