Clinical Trial Associate

Duties and Responsibilities

• Work on assignments and problems of limited scope, requiring independent decision-making and initiative, using standard procedures under close supervision.
• Solicit Clinical Study Execution Team (CSET) meeting agenda topics, coordinate meetings, minutes, and logistical support.
• Support site management activities and provide status to CSET (e.g., tracking site documents, distributing study materials, site enrollment metrics, etc.).
• Liaise with internal teams and vendors for document collection and updates; act as the primary CTA contact on studies.
• File study documents to the Trial Master File (TMF) and assist with TMF reviews. Maintain TMF and ensure document quality and completeness.
• May assist with protocol amendment documentation and version control.
• May assist with development of basic department initiatives, process documents, and standard forms most used by CTAs.
• Support other clinical operations activities as appropriate.

Requirements and Qualifications

• BS, BA, or RN in a relevant scientific discipline. 0-3 years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
• Basic understanding of FDA and EMA Regulations, ICH guidelines, GCP, and familiarity with standard clinical operation procedures (SOPs).
• Basic organization and communication skills.
• Proficient in MS Office (Word, Excel, Outlook) and project tracking tools.
• Demonstrate reliability, proactive communication, and quality in task execution.
• Apply knowledge of Clinical Operations in day-to-day assigned tasks.
• Thrive in a collaborative team setting and be driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• Travel may be required (~10%).

Preferred Qualifications

• Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience preferred.

Desired Skills and Experience

• Clinical Operations
• Clinical Trial Support
• Clinical Study Start-Up
• Clinical Study Maintenance
• Clinical Study Close-Out
• Site Management Support
• Clinical Study Execution Team Coordination
• Meeting Coordination
• Meeting Minutes
• Study Document Tracking
• Study Material Distribution
• Site Enrollment Tracking
• Vendor Coordination
• Cross-Functional Collaboration
• Trial Master File (TMF)
• TMF Maintenance
• TMF Review
• Document Quality Control
• Protocol Amendments
• Version Control
• Process Documentation
• FDA Regulations
• EMA Regulations
• ICH Guidelines
• Good Clinical Practice (GCP)
• Standard Operating Procedures (SOPs)
• eTMF
• EDC
• IRT
• CTMS
• Microsoft Word
• Microsoft Excel
• Microsoft Outlook
• Project Tracking
• Oncology
• Organization
• Communication
• Attention to Detail