Senior Clinical Research Associate

Why This Role Matters

Late-phase and post-marketing studies play a crucial role in understanding how therapies perform in real-world settings. Phase IV, Post-Marketing Surveillance (PMS), and Real-World Evidence (RWE) studies provide critical insights into long-term safety, effectiveness, and patient outcomes beyond controlled clinical environments. These studies directly influence regulatory decisions, labeling updates, and treatment guidelines.
As a Senior Clinical Research Associate (CRA) at ICON plc, you will be at the forefront of ensuring that post-approval and observational studies are conducted with the highest standards of quality, compliance, and patient safety. Your oversight will ensure that data collected reflects real-world clinical practice while maintaining strict adherence to Good Clinical Practice (GCP) and regulatory requirements. This role is essential to strengthening confidence in marketed therapies and supporting evidence-based healthcare decisions.

Job Description

The Senior CRA (Bangalore – Office-Based) is responsible for monitoring and overseeing Phase IV, PMS, and RWE clinical studies. This role ensures that clinical sites conduct research activities in compliance with study protocols, regulatory guidelines, and sponsor requirements.
The position requires independent monitoring capabilities, strong stakeholder coordination, and the ability to manage multiple studies simultaneously. The Senior CRA acts as a key liaison between study sites, sponsors, CRO partners, and internal cross-functional teams, ensuring seamless trial execution and data integrity throughout the study lifecycle.

Key Features of the Role

• Focus on Phase IV, PMS, and Real-World Evidence studies
• Office-based role with site monitoring responsibilities
• Exposure to late-phase and observational research programs
• Independent study management responsibilities
• Cross-functional collaboration with medical, regulatory, and vendor teams
• Opportunity to mentor junior CRAs
• Career progression toward Lead CRA or Clinical Trial Manager roles

Responsibilities

• Monitor clinical trial sites to ensure compliance with study protocols, regulatory requirements, and ICH-GCP standards.
• Conduct on-site and remote monitoring visits, including site initiation, interim, and close-out visits.
• Review source documentation and verify data accuracy and completeness.
• Identify protocol deviations, documentation gaps, and compliance risks, ensuring timely resolution.
• Oversee informed consent processes and patient safety reporting.
• Ensure timely and accurate case report form (CRF) completion and query resolution.

• Support PMS and RWE data collection processes aligned with observational study frameworks.
• Maintain oversight of safety reporting requirements, including adverse event documentation.
• Collaborate with Data Management, Regulatory Affairs, and Medical teams for issue resolution.
• Provide guidance and training to site personnel to ensure adherence to quality standards.
• Mentor junior CRAs and contribute to performance development initiatives.

• Build and maintain effective working relationships with investigators and site staff.
• Ensure essential documents are maintained and audit-ready.
• Prepare monitoring reports and maintain accurate documentation of visit findings.
• Manage study timelines, site performance metrics, and escalation of critical issues.

Required Qualifications

• Strong knowledge of Phase II–IV clinical trial processes.
• In-depth understanding of ICH-GCP guidelines and regulatory compliance standards.
• Proven ability to independently manage multiple clinical studies.
• Strong administrative and documentation skills.
• Ability to analyze site performance and implement corrective actions.
• Effective stakeholder communication and coordination skills.
• Strong problem-solving and decision-making capabilities.

Educational Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or related scientific discipline.
• Advanced degree preferred but not mandatory.
• Clinical research certification is an added advantage.

Experience and Skills

• Minimum 5+ years of experience in clinical research.
• 2–3 years of CRA/monitoring experience, preferably involving Phase II–IV studies.
• Essential experience in PMS, RWE, or post-marketing studies.
• Experience working with CROs, sponsors, and cross-functional medical teams.
• Strong knowledge of regulatory documentation and monitoring visit processes.
• Experience in safety reporting and risk-based monitoring approaches.
• Ability to independently handle multiple sites and protocols.
• Proficiency in clinical trial management systems (CTMS) and EDC platforms.
• Excellent written and verbal communication skills.

Salary Insights

Compensation is competitive and aligned with industry standards for Senior CRA roles within global CRO environments. Salary may vary depending on experience, therapeutic expertise, and prior exposure to Phase IV or RWE studies.

In addition to base compensation, employees at ICON plc may receive:
• Comprehensive health insurance plans
• Retirement savings programs
• Annual leave entitlements
• Life assurance coverage
• Global Employee Assistance Programme (LifeWorks)
• Flexible country-specific benefits and wellness programs

ICON’s total rewards approach emphasizes financial stability, career growth, and work-life balance.

Company Overview

ICON plc is a global leader in healthcare intelligence and clinical research services. The organization partners with pharmaceutical, biotechnology, and medical device companies to accelerate the development and commercialization of innovative therapies.
With operations across multiple regions, ICON delivers expertise across all phases of clinical development, including post-marketing and real-world evidence studies. The company fosters a culture of inclusion, performance excellence, and continuous professional development.
Inclusion and belonging are central to ICON’s values. The company is committed to maintaining an accessible and equitable workplace for all candidates and employees.

FAQs

1. Is Phase IV or PMS experience mandatory?
Yes, prior experience in PMS, RWE, or post-marketing studies is essential for this role.

2. Is this a field-based CRA role?
This is primarily office-based in Bangalore but involves monitoring responsibilities, including site visits as required.

3. Does the role include mentoring responsibilities?
Yes, senior-level CRAs may provide guidance and training to junior team members.

4. What are the growth prospects?
Career advancement may include Lead CRA, Clinical Trial Manager, or Project Management roles.

5. Is independent study management expected?
Yes, the candidate should be capable of independently managing multiple studies and sites.

Application Tips

• Highlight your Phase IV, PMS, and RWE experience clearly in your resume.
• Quantify monitoring experience (number of sites managed, visits conducted, etc.).
• Demonstrate knowledge of GCP and regulatory compliance.
• Mention experience handling safety reporting and protocol deviations.
• Showcase examples of stakeholder coordination and problem resolution.
• Emphasize independent study management capabilities.