Clinical Research Associate (CRA)

Roles & Responsibilities
• Conduct Site Selection Visits (SSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), and Close-Out Visits (COV)
• Ensure clinical trials are conducted in compliance with ICH-GCP guidelines, SOPs, and applicable regulatory requirements
• Monitor study progress to ensure adherence to approved protocol, timelines, and quality standards
• Perform Source Data Verification (SDV) and validate CRF/eCRF entries for accuracy and completeness
• Identify, document, and follow up on protocol deviations, discrepancies, and corrective actions
• Maintain, review, and update Trial Master File (TMF) documentation
• Ensure proper informed consent process compliance and documentation
• Coordinate with investigators, site staff, CROs, and sponsors for smooth study execution
• Track, review, and report Serious Adverse Events (SAEs) as per regulatory timelines
• Prepare detailed monitoring visit reports and follow-up letters
• Support audit and inspection readiness by ensuring documentation accuracy and completeness
• Assist in regulatory submissions and essential document management

Qualification
• B.Pharm (Bachelor of Pharmacy) / M.Pharm (Master of Pharmacy)
• BSc / MSc in Life Sciences, Clinical Research, or related discipline

Experience
• 1–2 years of hands-on experience in clinical trial monitoring
• Working knowledge of ICH-GCP guidelines
• Experience in TMF maintenance and SAE reporting

Skills
• Strong clinical trial monitoring expertise
• Proficiency in Source Data Verification (SDV)
• Experience with eCRF documentation and review
• Strong understanding of regulatory compliance frameworks
• Excellent documentation and reporting skills
• Strong communication and site coordination abilities
• Ability to manage multiple study activities efficiently
• High attention to detail and quality-focused approach

About the Organization
Desun Hospital is a multi-specialty healthcare institution in Kolkata with a structured clinical research environment. The hospital provides opportunities for clinical research professionals to gain hands-on experience in monitoring, regulatory compliance, and investigator coordination within a hospital-based research setup.