Senior Clinical Trial Associate

Key Responsibilities

• 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.
• 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.
• 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.
• Aid in the preparation, submission, and tracking of regulatory and IRB/IEC documents.
• 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.
• 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.
• 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.
• Proactively identify operational issues and risks, propose solutions, and escalate 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 and contributing to team capability building.

Requirements

• Bachelor’s degree in life sciences, clinical research, or a related field.
• Relevant certifications (e.g., CRC, CRA) are a plus.
• Minimum of 3–5 years of experience as a Clinical Trial Associate or in a similar clinical research role.
• Demonstrated experience supporting trial coordination, regulatory documentation, and site management activities.
• Oncology trial experience required; cell therapy and/or CAR-T experience strongly preferred.
• Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes.
• Proficiency with CTMS, eTMF, and EDC systems.
• Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Strong written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.