Senior Clinical Trial Associate

Role Overview Senior Clinical Trial Associate (Sr. CTA) on the Clinical Operations team to support early-stage clinical development, executing complex Phase I/II CAR-T oncology trials with operational, administrative, and coordination support. Key Responsibilities Provide cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study forums. Support Senior Clinical Trial Managers with day-to-day execution of Phase I/II CAR-T oncology trials in compliance with ICH-GCP and applicable regulations. Oversee preparation, organization, and maintenance of trial documentation (regulatory files, TMFs/eTMFs, correspondence); ensure documents are current, complete, and compliant with ICH-GCP and company SOPs. Assist with trial planning, start-up, execution, and close-out; coordinate with sites and support protocol/regulatory compliance. Prepare, submit, and track regulatory and IRB/IEC documents; maintain knowledge of applicable regulations and standards. Schedule/coordinate meetings (investigator meetings, site visits, internal meetings); prepare agendas, minutes, track action items. Track trial progress (site activation, enrollment, monitoring, milestones) and maintain status reports/trackers. Support data management (query tracking and data reconciliation) with Data Management. Liaison among clinical team, vendors, CROs, and investigational sites; support vendor oversight. Identify operational issues/risks, propose solutions, and elevate as appropriate; improve processes; mentor junior CTAs. Requirements Bachelor’s degree in life sciences/clinical research or related field. 3–5 years as a Clinical Trial Associate (or similar role). Experience with trial coordination, regulatory documentation, and site management. Oncology trial experience required; cell therapy and/or CAR-T strongly preferred. Strong ICH-GCP/regulatory understanding; proficiency with CTMS, eTMF, and EDC. Excellent organization, communication, problem-solving; ability to work cross-functionally. Proficiency in Microsoft Office; familiarity with eTMF/EDC platforms. Benefits Benefits are offered exclusively to permanent full-time employees (contractors not eligible). Work Authorization Applicants must be authorized to work in the United States; E-Verify and Form I-9 required if hired. #J-18808-Ljbffr