Clinical Trials Investigator

Role & responsibilities

• Design, develop, prepare and initiate clinical study protocols and required documentation in compliance with project plans, Federal/DCGI regulations, GCP and good medical practice
• Participate in the selection of clinical investigators; provide proper investigator profile for study. Visit selected sites to troubleshoot, train/retrain staff if needed
• Provide medical supervision and training for project teams, study investigational sites and other involved organizations, for the understanding and delivery of study protocol
• Provide medical and scientific input to review of clinical data, patient medical safety data and laboratory values; maintain an ongoing assessment of the safety profile and efficacy data
• Provide medical surveillance on Serious Adverse Event (SAE) reporting, follow‑ups, including after hours coverage of medical emergencies
• Responsible for medical review of the cases in pharmacovigilance database
• Participate in the planning, writing and review of Clinical Study Reports, regulatory updates and submissions
• Analyze and interpret study data and prepare reports
• Participate as an active member of multidisciplinary teams to successfully achieve corporate goals. Specific responsibilities include interacting with project management and clinical operations to provide estimate for operational budgets, and assess laboratory requirements
• Any other duties as assigned by the supervisor in the department

• 2-3 Years CR experience
• Qualification:
  
  MBBS
• MS Office
• Requirements of Good Clinical Practices
• Requirements of Good Documentation Practices
• Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records