Clinical Trial Associate (CTA)

Job Description

Clinical Trial Associate | Sumitomo Pharma America, Inc.

The Tone:
This is a full-time role at Sumitomo Pharma America, Inc., primarily remote with periodic on-site meetings. Sumitomo Pharma is a global pharmaceutical company focused on addressing patient needs across oncology, urology, women’s health, rare diseases, cell & gene therapies, and CNS, with a mission to accelerate the delivery of novel therapies to patients. This role is crucial for supporting the operational and regulatory execution of clinical trials, ensuring the integrity and compliance of trial records in alignment with clinical standards and Good Clinical Practice. The Clinical Trial Associate directly contributes to the efficient progression of investigational assets from early- to late-stage development.

The TL;DR
• Role: Early Career
• Type: Full-time
• Location: Primarily remote with periodic on-site meetings
• Pay: $72900–$91100 yearly
• Mission: To support the operational and regulatory execution of clinical trials, ensuring document integrity, compliance, and effective communication for the timely development of novel therapies.
• Tech Stack: Microsoft Office (Word, Excel, PowerPoint, Outlook), Smartsheet, MS Project, SharePoint, electronic Trial Master File systems

What You’ll Actually Do
• Study Execution: Support the execution and maintenance of clinical trials by performing essential tracking, document coordination, and communication activities, ensuring regulatory compliance and protocol adherence.
• Document Control: Review, organize, and ensure accuracy of key study documents, identifying discrepancies and proactively resolving issues with sites or team members.
• Data Management: Maintain and update critical study trackers, databases, and platforms to ensure real-time accuracy and audit readiness, identifying potential risks to document completeness or compliance.
• Progress Monitoring: Monitor overall study progress by regularly collecting and synthesizing data on site status, enrollment, and regulatory submissions, providing timely updates to facilitate effective decision-making.
• Logistical Coordination: Manage the logistical aspects of clinical trial materials, including clinical and non-clinical supplies and laboratory sample shipments, ensuring chain of custody and protocol requirements are met.

The Must-Haves
• Background: Bachelor’s degree in a scientific, healthcare, or related discipline, or an equivalent combination of education and experience.
• Experience: Minimum of 1 year of experience in clinical research, healthcare, or life sciences is preferred, though qualified entry-level candidates with relevant internship or academic project experience will be considered.
• Skills: Proficient in Microsoft Office and familiar with project management/collaboration tools; strong written and verbal communication skills; excellent organizational skills and attention to detail; demonstrated ability to independently manage multiple priorities in a deadline-driven environment.