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Parexel is hiring a Clinical Research Associate I (CRA I) in Bengaluru, offering an excellent opportunity for life science and pharmacy graduates to build a strong career in clinical research, site monitoring, patient recruitment, and regulatory compliance. This role is ideal for candidates eager to work with a global CRO committed to improving patient health worldwide.
This detailed job guide covers responsibilities, qualifications, benefits, and application steps—structured to help you decide confidently.
Key Responsibilities
Site Management & Monitoring
- Serve as Parexel’s primary contact for assigned clinical trial sites.
- Monitor clinical site performance from initiation to close-out.
- Ensure site compliance with study protocols, ICH-GCP, and regulatory requirements.
- Identify issues related to quality, documentation, data integrity, and site readiness.
- Conduct qualification, initiation, monitoring, and close-out visits.
- Perform remote site contacts and maintain high-quality visit documentation.
Study Oversight & Quality
- Ensure timely CRF data entry, query resolution, and SAE reporting.
- Manage clinical trial supplies: accountability, reconciliation, and returns.
- Maintain audit-ready site documentation and ensure TMF completeness.
- Evaluate site recruitment plans and develop improvement strategies.
- Support investigator and site staff training.
Collaboration & Reporting
- Update Clinical Trial Management Systems (CTMS, EDC, IVRS).
- Participate in team meetings, audits, and regulatory inspections.
- Coordinate with internal stakeholders on study milestones and deliverables.
- Maintain strong professional relationships with investigators and site staff.
Required Qualifications
Education
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related field (mandatory).
Experience
- Prior experience in site management or clinical research is required.
- Understanding of clinical trial methodology, regulatory requirements, and ICH-GCP.
Technical Skills
- Strong proficiency in CTMS, EDC, MS Office (Word, Excel).
- Ability to generate monitoring reports and analyze site performance.
Behavioral Competencies
- Strong communication and interpersonal skills.
- Ability to work independently with minimal supervision.
- Excellent problem-solving, prioritization, and time management skills.
- Willingness to travel as required.
Benefits
- Opportunity to work with one of the world’s leading CROs.
- Exposure to global clinical trial operations and regulatory frameworks.
- Structured learning and development programs.
- Inclusive, collaborative, and performance-driven culture.
How to Apply
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