Roles & Responsibilities
• Maintain confidentiality of sponsor and clinical trial information
• Coordinate with subcontractors such as labs, translators, and document vendors
• Prepare and customize study documents including SMP, monitoring plans, ICFs, IMP labels, and trial forms
• Manage regulatory submissions, approvals, and related documentation
• Support investigator meetings and study-related communications
• Handle adverse event (AE) reporting during trial conduct
• Manage clinical trial supplies, drug accountability, and site documentation
• Develop, maintain, and ensure completeness of the Trial Master File (TMF)
• Plan and coordinate site initiation, monitoring, and close-out visits
• Coordinate with CRAs/CTAs, review monitoring reports, and support study databases
• Support data clarification, co-monitoring visits, and regular study updates
Qualification
• Degree in Pharmacy, Life Sciences, Clinical Research, or related discipline
Experience
• 0-6 months of experience in clinical research or clinical trial coordination
• Freshers with relevant academic exposure are eligible
Skills
• Basic knowledge of ICH-GCP and clinical trial processes
• Understanding of regulatory documentation and TMF management
• Strong communication, documentation, and coordination skills
• Ability to work with cross-functional teams and multiple stakeholders
• Willingness to join immediately
About the Company
Samahitha is a growing clinical research organization focused on delivering high-quality clinical trial support services, offering early-career professionals hands-on exposure to end-to-end clinical research operations in a structured and learning-driven environment.