Clinical Trial Associate

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Scope:

The Clinical Trial Associate (CTA) plays a key role in supporting the operational and regulatory execution of clinical trials, acting as a central resource to study teams, and handling administrative aspects of clinical trial execution. This position is responsible for coordinating study documentation, tracking essential project milestones, and ensuring the integrity and compliance of trial records in alignment with Clinical Standard Operating Procedures and Good Clinical Practice (ICH) Guidelines. The CTA utilizes specialized knowledge and critical thinking skills to identify, communicate, and resolve study-related compliance or operational issues. The CTA also contributes to process improvement initiatives and supports the preparedness of clinical trials for audits and regulatory inspections. This position requires the ability to work independently within established procedures, exercise sound judgment, and make recommendations to ensure study quality, accuracy, and regulatory readiness.

Key Responsibilities:

• Support the execution and maintenance of clinical trials by performing essential study tracking, document coordination, and communication activities, ensuring regulatory compliance and adherence to the study protocol.
• Review, organize, and ensure accuracy of key study documents (e.g., informed consent forms, regulatory documents, essential document packets) in accordance with established standards and SOPs. Identify discrepancies and proactively work with sites or team members to resolve issues, escalating when appropriate.
• Maintain and update critical study trackers, databases, and platforms (such as electronic Trial Master File systems) to ensure real-time accuracy and audit readiness. Apply subject matter knowledge to identify potential risks to document completeness or compliance and recommend process improvements.
• Monitor overall study progress by regularly collecting and synthesizing data on site status, enrollment, training completion, and regulatory submissions. Provide timely and concise updates to the team and partner functions to facilitate effective decision-making.
• Coordinate and prepare materials for study meetings (including drafting agendas, taking minutes, and following up on action items) to support cross-functional communication, alignment, and compliance.
• Manage the logistical aspects of clinical trial materials, including clinical and non-clinical supplies and laboratory sample shipment coordination, ensuring chain of custody and protocol requirements are met.
• Assist with the implementation of training for site personnel and vendors on study-specific procedures, leveraging knowledge of protocol requirements and regulatory guidelines.
• Contribute to the ongoing development and continuous improvement of departmental procedures, including participation in SOP reviews and recommendations based on study experience.
• Work independently within defined procedures, exercising discretion and sound judgment to resolve routine issues, and escalate matters with potential impact to study quality or milestone achievement.
• Assist or back up the Clinical Regulatory Operations Specialist in periodic quality control review and overall maintenance of the Trial Master File to ensure regulatory and inspection readiness.
• Perform other study-related duties and projects as assigned.

Professional Experience/Qualifications:

• Bachelor’s degree in a scientific, healthcare, or related discipline required; equivalent combination of education and experience may be considered.
• Minimum of 1 year of related experience in clinical research, healthcare, or life sciences preferred; open to qualified entry-level candidates with relevant internship or academic project experience.
• Proficient computer skills, including Mi