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
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