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 in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

We are currently seeking a student intern to join our team. The intern will work closely with the Clinical Operations department in the areas of Trial Execution. This role is a paid, hybrid role with some preferred in-office time. Oversight of the role will be managed by subject matter experts within the Clinical Operations Team.

Key Responsibilities: 

• Working with the Clinical Operations team on assigned tasks such as:
  • eTMF and Document Management
    • 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
  • Site Management and Monitoring Support
    • 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
  • Process Improvement and Departmental Initiatives
    • 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

The anticipated hourly rate for this position will be $20.00 to $25.00 per hour.  The actual hourly rate offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.