Clinical Operations Intern (Summer 2026)

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. They are currently seeking a student intern to work closely with the Clinical Operations department in the areas of Trial Execution, providing support in various tasks related to clinical trials.

Responsibilities

• Working with the Clinical Operations team on assigned tasks such as:
• Perform quality control checks on electronic Trial Master Files
• Assist in compiling and reviewing essential document packets required to activate new clinical sites
• Classify and tag uncategorized documents for audit preparedness
• Provide support and become a key point of contact for contract and budget tracking related activities
• Assist the clinical trial execution team in monitoring trip report review
• Assess site and master level Informed Consent documents to ensure compliance with company SOPs
• Provide team assistance related to assigned Corrective Action Plans activities
• Optimize, maintain, and innovate trackers and tools utilized by the clinical operations team
• Collate documents related to SOPs and training
• Support ongoing initiatives to gather historical information on study specifics to develop a comprehensive and accurate database
• Develop an understanding and knowledge of GCP and industry clinical operations standards
• Preparation of department minutes
• Collaborate with cross-functional stakeholders as needed

Skills

• Currently enrolled as a student in a relevant field of study
• Ability to work in a hybrid role with some preferred in-office time
• Strong attention to detail for quality control checks on electronic Trial Master Files
• Ability to assist in compiling and reviewing essential document packets required to activate new clinical sites
• Skills in classifying and tagging uncategorized documents for audit preparedness
• Experience in providing support for contract and budget tracking related activities
• Ability to assist the clinical trial execution team in monitoring trip report review
• Knowledge of assessing site and master level Informed Consent documents to ensure compliance with company SOPs
• Experience in providing team assistance related to assigned Corrective Action Plans activities
• Skills in optimizing, maintaining, and innovating trackers and tools utilized by the clinical operations team
• Ability to collate documents related to SOPs and training
• Experience in supporting ongoing initiatives to gather historical information on study specifics
• Understanding of GCP and industry clinical operations standards
• Ability to prepare department minutes
• Skills in collaborating with cross-functional stakeholders as needed

Company Overview