Study Coordinator I

Overview

Remote Study Coordinator I role supporting the planning, coordination, execution, and reporting of drug metabolism and pharmacokinetic studies.

What you'll do

• Coordinate study activities, including protocol preparation, study scheduling, milestone tracking, and status updates using study outlines and client-provided information.
• Monitor study progress against agreed plans, identify potential delays or risks, and proactively follow up on critical milestones.
• Coordinate study initiation activities, pre-initiation meetings, and other study-related discussions.
• Support the coordination of multiple studies simultaneously, prioritizing activities based on timelines, complexity, and business needs.
• Review study activities for consistency with approved protocols, applicable SOPs, client-specific requirements, and relevant regulatory guidelines.
• Support study progress tracking and archiving activities, ensuring records are complete, traceable, and appropriately maintained.
• Support the preparation and finalization of scientific study reports, including report shelling, tables, figures, and compilation of information from laboratory and analytical groups.
• Perform QC of data, tables, and figures to ensure accuracy, consistency, and completeness.
• Coordinate protocol and report reviews, address reviewer and client comments, and support study finalization.
• Drive report production activities from initial preparation through review, finalization, distribution, and archival, while maintaining agreed timelines.
• Serve as a coordination point for assigned studies, facilitating timely communication, follow-ups, and resolution of outstanding actions.
• Support global teams across different sites, ensuring continuity of communication and alignment on study priorities.

What you'll need

• Master's in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• 2 years of relevant experience in study coordination.
• Ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers.

Nice to have

• Knowledge in Drug Metabolism and Pharmacokinetic Studies.
• Experience in study coordination, pharmacokinetics, drug metabolism, laboratory operations, or scientific report preparation.

Details

• Remote based, Monday - Friday, 11 AM to 8 PM.
• Location: Bengaluru, India.