Clinical Trial Assistant/Sr. Clinical Trial Assistant

The Clinical Trial Assistant (CTA) / Senior Clinical Trial Assistant (Sr. CTA) is a sponsor-side role responsible for providing administrative and operational support to the Clinical Study Team while maintaining sponsor oversight of the Trial Master File (TMF) to ensure continuous inspection readiness.

This role supports one or more fully outsourced, global clinical studies and works closely with CRO partners, the Clinical Trial Manager, and cross-functional study team members to ensure essential documentation is complete, accurate, timely, and inspection-ready throughout the study lifecycle. Education

• Bachelor’s degree in life sciences, healthcare, or related field preferred

 
Experience
 
Clinical Trial Assistant (CTA):

• 1–3+ years of experience supporting clinical trials (CTA, TMF, or clinical operations role)

 
Senior Clinical Trial Assistant (Sr. CTA):

• 4–6+ years of clinical research or clinical operations experience
• Demonstrated experience supporting global, outsourced clinical trials with increasing responsibility

 
Required Skills & Knowledge
 

• Working knowledge of Trial Master File (TMF) processes and systems (e.g., Veeva Vault or equivalent)
• Understanding of ICH GCP and ALCOA+ data integrity principles
• Experience working with CROs and cross-functional study teams
• Strong organizational skills and attention to detail
• Ability to manage multiple priorities in a fast-paced, global environment
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)

  Clinical Trial Support

• Provide administrative and coordination support to the Clinical Study Team
• Prepare meeting agendas, minutes, and materials for study team, vendor, and governance meetings
• Create, maintain, and track study-related documentation and logs
• Support coordination of clinical trial activities across internal teams and external vendors

 
Trial Master File (TMF) Oversight

• Support maintenance of the TMF or provide sponsor-side oversight of CRO-managed eTMF
• Review TMF content for completeness, quality, and timeliness
• Partner with CRO TMF teams to identify and resolve discrepancies
• Contribute to ongoing inspection readiness and audit support activities

 
Cross-Functional Collaboration

• Coordinate activities with clinical, regulatory, data management, and quality teams
• Support communication between internal stakeholders and CRO partners
• Assist with tracking study deliverables and timelines

 
General Clinical Operations Support

• Support additional clinical operations activities as needed across the study lifecycle
• Maintain strong documentation practices aligned with regulatory expectations

• Medical, Dental, Vision Insurance
• Life/AD&D
• Short- and Long-Term Disability
• 401(K) with large company match
• Health Saving Account (HSA) and Flexible Spending Account (FSA) with company match
• Wellness Program
• Employee Assistance Program (EAP)
• Generous Paid Time Off (PTO)

 

Disclaimer: The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.