Clinical Research Associate

Roles & Responsibilities
• Perform clinical monitoring and site management activities to ensure study conduct as per protocol, GCP, ICH, and sponsor requirements
• Conduct site selection, initiation, routine monitoring, and close-out visits in line with contracted scope of work
• Support and track subject recruitment plans in collaboration with study sites to meet project timelines
• Deliver protocol and study-related training to assigned sites and maintain ongoing communication
• Evaluate site quality, data integrity, and protocol compliance, escalating issues where required
• Track regulatory submissions, ethics approvals, recruitment, enrollment, and CRF completion
• Support start-up activities and ensure study milestones are achieved
• Ensure essential documents are filed correctly in the Trial Master File (TMF) and Investigator Site File (ISF)
• Prepare monitoring visit reports, follow-up letters, and site management documentation
• Collaborate with cross-functional study team members to support project execution
• Support site-level subject recruitment planning where applicable
• Assist with site financial management, invoice collection, and trial agreement compliance when required

Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related discipline

Experience
• Minimum 3+ years of relevant experience as a Clinical Research Associate
• Experience in site monitoring, trial start-up, and close-out activities
• Exposure to multicentre clinical trials preferred

Skills
• Strong knowledge of ICH-GCP, regulatory guidelines, and clinical trial processes
• Proven site monitoring and site management skills
• Ability to manage multiple studies and priorities effectively
• Strong written and verbal communication skills
• Good documentation, reporting, and organisational abilities
• Ability to work independently and collaboratively in project teams

About the Company
IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. Operating across multiple regions in India and worldwide, IQVIA supports the development and commercialization of innovative therapies through high-quality, compliant, and data-driven clinical research solutions.