Clinical Operations Intern (Summer 2026)

Remote, USA Full-time
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 Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. It was founded in 1949, and is headquartered in Princeton, New Jersey, US, with a workforce of 501-1000 employees. Its website is
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