Clinical Research Coordinator
Parel, Maharashtra, India
• Successfully handled multiple trials in compliance with ICH - GCP guidelines. • Developed and implemented patient recruitment plans to ensure successful trial. • Responsible for operational aspects of clinical trials including delivery of study on time. • Preparing regulatory submissions & supporting documents for IRB review and sponsor records. • Drug accountability and maintaining logs. • Submission of study related documents (Amendments, SAEs, Annual status reports etc) to the Ethics Committee on a timely basis in accordance with IEC SOP. • Participate in the review of clinical research documents (e.g. Protocols, Case Report forms, Reports And statistical analysis) • Monitoring Intramural trials ( Pre study Visit, Site Initiation Visit, Routine Monitoring) • Identifying site issues and initiates correction plans based on monitoring reports.• CTRI Registration.