Clinical Research Associate II – CRA
Location: Bengaluru, India
Job Type: Full-Time, Regular
Experience Required: Fresher – 2+ years
About Parexel
Parexel is a global leader in clinical research services, dedicated to accelerating the development of therapies and treatments that improve patient lives. With a presence across multiple therapeutic areas and countries, Parexel provides end-to-end clinical research solutions, offering CRAs the opportunity to work on high-impact global projects while developing professionally in a collaborative, innovative environment.
Role Overview
As a Clinical Research Associate (CRA) II, you will serve as the primary point of contact for assigned clinical sites, ensuring patient safety, protocol compliance, and the integrity of clinical trial data. You will manage all aspects of site monitoring from initiation through close-out, including site qualification, regulatory compliance, patient recruitment strategy, and performance evaluation.
This role is open to freshers with a degree in life sciences, pharmacy, or nursing, providing an opportunity to gain comprehensive exposure to clinical trial operations, regulatory compliance, and site management.
Key Responsibilities
Act as Parexel’s direct liaison with assigned clinical sites and ensure trial conduct adheres to protocol, ICH-GCP guidelines, and regulatory requirements.
Build strong relationships with investigators and site staff to ensure optimal study execution.
Perform site initiation, monitoring, and close-out visits, including evaluation of site performance, patient recruitment, and staff training needs.
Assess and address issues related to site compliance, data quality, and study timelines; implement corrective actions when necessary.
Facilitate site access to relevant study systems and ensure compliance with project-specific training requirements.
Review and approve site documentation, including regulatory documents, CRFs, and TMF submissions, ensuring completeness and accuracy.
Provide strategic input on patient recruitment plans and site performance improvement.
Conduct remote visits and communications when required, generating detailed visit reports.
Ensure study readiness for audits and inspections, maintaining compliance with sponsor and Parexel SOPs.
Collaborate with cross-functional teams, including clinical operations, data management, and quality assurance.
Maintain high-quality documentation of all activities and contribute to continuous process improvements.
Required Skills & Competencies
Strong verbal, written, and interpersonal communication skills.
Detail-oriented with strong analytical and problem-solving abilities.
Ability to work independently and collaboratively in a team-oriented, matrix environment.
Strong organizational, planning, and multitasking skills.
Client-focused approach with flexibility and adaptability.
Proficient in CTMS, EDMS, and Microsoft Office Suite.
Commitment to patient safety, data integrity, and regulatory compliance.
Willingness to travel extensively to assigned sites as per project requirements.
Educational Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or other health-related disciplines.
Equivalent clinical research or healthcare experience may be considered.
Experience
Fresher-friendly: Open to candidates with minimal or no prior clinical research experience.
Internships, research exposure, or coursework in clinical trials is advantageous.
Why Join Parexel
Work on global clinical trials across diverse therapeutic areas.
Gain exposure to site management, regulatory compliance, and clinical operations.
Develop professional skills in a dynamic, collaborative, and high-impact environment.
Build a strong foundation for a career in clinical research and healthcare innovation.
This version is GPT-optimized for SEO, targeting keywords like: Clinical Research Associate Bengaluru, CRA jobs India fresher, clinical trials site monitoring, ICH-GCP compliance, Parexel careers.
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