Senior Clinical Trial Associate
Legend Biotech
5 months ago
Remote
United States
Clinical Research and Development
Role Overview
Senior Clinical Trial Associate (Sr. CTA) for early-stage clinical development; support execution of complex Phase I/II CAR-T oncology clinical 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-related forums.
- Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials in compliance with ICH-GCP and applicable regulatory requirements.
- Oversee 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 planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities.
- Assist with preparation, submission, and tracking of regulatory and IRB/IEC documents; maintain working knowledge of applicable regulations and standards.
- Schedule and coordinate study meetings (investigator meetings, site visits, internal team meetings); prepare agendas, document minutes, track action items, and follow up.
- Assist in tracking trial progress (site activation, enrollment, monitoring activities, key milestones) and prepare study status reports/trackers.
- Support data management activities including query tracking and data reconciliation with Data Management.
- Serve as liaison between clinical team, vendors/CROs, and investigational sites; assist with vendor oversight (deliverables, timelines, operational issue resolution).
- Proactively identify operational issues/risks, propose solutions, and escalate to Clinical Operations leadership as appropriate.
- Contribute to continuous improvement of clinical operations processes and best practices.
- Provide guidance/mentorship to junior CTAs.
Requirements
- Education: Bachelor’s degree in life sciences, clinical research, or related field; relevant certifications (e.g., CRC, CRA) a plus.
- Experience: 3–5 years as a Clinical Trial Associate or similar role; experience supporting trial coordination, regulatory documentation, and site management. Oncology and/or autoimmune disease trial experience required; cell therapy and/or CAR-T experience strongly preferred.
- Skills/Competencies: Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes; proficiency with CTMS, eTMF, and EDC; excellent organization and communication; detail-oriented with analytical/problem-solving skills; ability to work independently and collaboratively cross-functionally.
- Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.
Senior Clinical Trial Associate (Sr. CTA) for early-stage clinical development; support execution of complex Phase I/II CAR-T oncology clinical 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-related forums.
- Support Senior Clinical Trial Managers in the day-to-day execution of complex Phase I and Phase II CAR-T oncology trials in compliance with ICH-GCP and applicable regulatory requirements.
- Oversee 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 planning, start-up, execution, and close-out of clinical trials, including coordination with clinical sites and support of protocol and regulatory compliance activities.
- Assist with preparation, submission, and tracking of regulatory and IRB/IEC documents; maintain working knowledge of applicable regulations and standards.
- Schedule and coordinate study meetings (investigator meetings, site visits, internal team meetings); prepare agendas, document minutes, track action items, and follow up.
- Assist in tracking trial progress (site activation, enrollment, monitoring activities, key milestones) and prepare study status reports/trackers.
- Support data management activities including query tracking and data reconciliation with Data Management.
- Serve as liaison between clinical team, vendors/CROs, and investigational sites; assist with vendor oversight (deliverables, timelines, operational issue resolution).
- Proactively identify operational issues/risks, propose solutions, and escalate to Clinical Operations leadership as appropriate.
- Contribute to continuous improvement of clinical operations processes and best practices.
- Provide guidance/mentorship to junior CTAs.
Requirements
- Education: Bachelor’s degree in life sciences, clinical research, or related field; relevant certifications (e.g., CRC, CRA) a plus.
- Experience: 3–5 years as a Clinical Trial Associate or similar role; experience supporting trial coordination, regulatory documentation, and site management. Oncology and/or autoimmune disease trial experience required; cell therapy and/or CAR-T experience strongly preferred.
- Skills/Competencies: Strong understanding of ICH-GCP, regulatory requirements, and clinical trial processes; proficiency with CTMS, eTMF, and EDC; excellent organization and communication; detail-oriented with analytical/problem-solving skills; ability to work independently and collaboratively cross-functionally.
- Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with eTMF and EDC platforms.