Clinical Study Start-Up Associate

Clinical Study Start-Up Associate role in Boston supporting clinical trial activation and documentation. Coordinate study start-up activities, manage regulatory and site activation documents, and partner with cross-functional teams to ensure timely trial initiation.

Responsibilities

• Support study start-up activities from protocol finalization through site activation
• Coordinate, review, track, and maintain critical study documents including protocols, informed consent forms, and regulatory submissions
• Perform quality checks of documentation and maintain inspection-ready trial master files in ICH-GCP compliance
• Track study start-up milestones including regulatory approvals and site activation status
• Partner with Clinical Operations, Regulatory, and CROs to resolve start-up action items

Requirements

• Highly organized with ability to manage multiple complex projects simultaneously
• Experience coordinating clinical trial start-up or regulatory documentation processes
• Knowledge of ICH-GCP guidelines and clinical trial management standards
• Strong attention to detail and quality assurance capabilities
• Proficiency in document management systems and spreadsheet tools
• Excellent cross-functional communication and stakeholder coordination skills