Senior Clinical Trial Associate; Contractor

Responsibilities

• •CTA will play a critical role in the execution of complex Phase I/II CAR‑T oncology clinical trials by providing high‑quality operational, administrative, and coordination support
• •The ideal candidate will have substantial experience in clinical trial operations and administration, with a strong understanding of clinical trial processes, regulatory requirements, and GCP
• •This role is critical to ensuring the efficient execution of clinical trials, maintaining regulatory compliance, and providing operational support to cross‑functional study teams
• •Clinical Trial Operations Support
• •Provide cross‑functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study‑related forums
• •Support Senior Clinical Trial Managers in the day‑to‑day execution of complex Phase I and Phase II CAR‑T oncology trials, ensuring all activities are conducted in compliance with ICH‑GCP and applicable regulatory requirements
• •Documentation & TMF Management
• •Oversee the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence
• •Ensure documentation is current, complete, and compliant with ICH‑GCP and company SOPs
• •End‑to‑End Trial Coordination
• •Assist with the planning, start‑up, execution, and close‑out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities
• •Regulatory & Compliance Support
• •Assist with the preparation, submission, and tracking of regulatory and IRB/IEC documents
• •Maintain working knowledge of applicable regulations and standards to support ongoing study compliance
• •Meeting & Communication Coordination
• •Schedule and coordinate study meetings, including investigator meetings, site visits, and internal team meetings
• •Prepare meeting agendas, document minutes, track action items, and follow up to ensure timely completion
• •Tracking, Reporting & Data Support
• •Assist in tracking trial progress, including site activation, enrollment, monitoring activities, and key study milestones
• •Prepare and maintain study status reports and trackers for internal and external stakeholders
• •Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management
• •Site & Vendor Support
• •Serve as a key liaison between the clinical trial team, vendors, CROs, and investigational sites to ensure clear and timely communication
• •Assist with vendor oversight by tracking deliverables, timelines, and resolving operational issues
• •Problem Solving & Continuous Improvement
• •Proactively identify operational issues and risks, propose solutions, and elevate to the Senior Clinical Trial Manager or Clinical Operations leadership as appropriate
• •Contribute to the development and continuous improvement of clinical operations processes and best practices
• •Provide guidance and mentorship to junior CTAs, sharing best practices…
• •25 more items(s)