Clinical Research Assoicate

Job Title: Clinical Research Associate

(CRA)Department: Clinical ResearchReporting

Job Summary

The Clinical Research Associate (CRA) is responsible for monitoring clinical trials to ensure they are conducted in accordance with the approved protocol, ICH-GCP guidelines, SOPs, and applicable regulatory requirements. The CRA ensures subject safety, data accuracy, and overall study compliance.

Key Responsibilities

• Conduct Site Initiation Visits (SIV), Monitoring Visits (IMV), and Close-Out Visits (COV)
• Ensure protocol adherence and regulatory compliance at trial sites
• Verify source documents against CRFs/EDC
• Ensure Informed Consent Forms (ICF) are properly obtained and documented
• Review and report Adverse Events (AEs) and Serious Adverse Events (SAEs)
• Identify, document, and follow up on protocol deviations
• Train site staff on protocol, GCP, and study procedures
• Prepare and submit monitoring visit reports within timelines
• Coordinate with investigators, CRCs, sponsors, and internal teams
• Ensure proper TMF/ISF documentation
• Support audits and inspections when required

Required Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or related field
• Certification in Clinical Research / ICH-GCP preferred
• Knowledge of clinical trial phases (I–IV)

Skills & Competencies

• Strong understanding of ICH-GCP guidelines
• Excellent documentation and attention to detail
• Good communication and interpersonal skills
• Ability to manage multiple sites and timelines
• Willingness to travel (for on-site monitoring roles)
• Basic knowledge of EDC systems

Experience

• Freshers: Clinical Research Trainee / Internship experience preferred