Anand Sharma

Clinical Research Associate-i @Iqvia Middle East And Africa

Kolkata, IN

Primary point of contact for clinical projects, responsible for sponsor communication, issue resolution, and weekly progress updates.• Coordinate internal teams to ensure smooth study execution. Review study protocols and processes, including timelines, inclusion/exclusion criteria, confidentiality, and data privacy protections.• Conduct site evaluations, initiations, monitoring, and closeout visits. • Manage feasibility documentation, budget negotiations, and finalization with investigators.• Handle regulatory/IRC submissions, respond to DCGI and other committee queries, and support auditors during inspections.• Identify investigators and lead patient recruitment for studies across multiple therapeutic areas, including vaccines, oncology, endocrinology, immunology, epidemiology, metabolic disorders, and pain management.• Deliver protocol training during site initiation. Monitor compliance with study protocols, GCP, and regulatory requirements. Coordinate with medical monitors for eligibility checks during screening and randomization.• Track subject recruitment and overall study progress while developing tools and logs for data review.• Ensure CRF accuracy, TMF completeness, source documents, ICDs, and AE/SAE reporting are maintained and audit-ready.• Conduct IP reconciliation and manage all site binders and logs. Escalate significant issues such as protocol deviations and safety events. Develop and implement recruitment strategies, build healthcare partnerships, and enhance patient retention while reducing recruitment costs.

Jawaharlal Nehru Technological University

Bachelor of Pharmacy