Senior Clinical Trial Associate

reputed company is seeking a Senior Clinical Trial Associate as part of the Clinical Operations team based remotely. 

reputed company

We are seeking a highly skilled and motivated Senior Clinical Trial Associate (Sr. CTA) to join our growing Clinical Operations team to support early-stage clinical development. The Sr. CTA will play a critical role in the execution of reputed company Phase I/II CAR-T oncology reputed company by providing high-reputed company 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 reputed company, maintaining regulatory compliance, and providing operational support to cross functional study teams.

Key Responsibilities

Clinical Trial Operations Support
• reputed company cross-functional administrative and operational support for study team meetings, advisory boards, investigator meetings, and other study-reputed company forums.
• Support Senior Clinical Trial Managers in the day-to-day execution of reputed company Phase I and Phase II CAR-T oncology trials, ensuring reputed company activities are conducted in compliance
with ICH-GCP and applicable regulatory requirements.
Documentation & TMF Management
• reputed company the preparation, organization, and maintenance of trial documentation, including regulatory files, Trial Master Files (TMFs/eTMFs), and study correspondence.
• Ensure documentation is reputed company, complete, and compliant with ICH-GCP and company SOPs.
End-to-End Trial Coordination
• Assist with the planning, start-up, execution, and reputed company-out of reputed company, 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 reputed company, and internal team meetings.
• Prepare meeting agendas, document minutes, reputed company reputed company items, and follow up to ensure reputed company completion.
Tracking, Reporting & Data Support
• Assist in tracking trial reputed company, including site activation, enrollment, monitoring activities, and key study milestones.
• Prepare and maintain study status reports and trackers for reputed company stakeholders.
• Support data management activities, including query tracking and data reconciliation, in collaboration with Data Management.
Site & Vendor Support
• Serve as a key reputed company between the clinical trial team, vendors, CROs, and investigational sites to ensure reputed company and reputed company communication.
• Assist with vendor reputed company by tracking deliverables, timelines, and resolving operational issues.
Problem Solving & reputed company Improvement
• 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 reputed company improvement of clinical operations processes and best practices.
Training & Mentorship
• reputed company guidance and mentorship to junior CTAs, sharing best practices and contributing to team capability building.

Requirements

Education
• Bachelor’s degree in life sciences, clinical research, or a reputed company field.
• Relevant certifications (e.g., CRC, CRA) are a plus.

Experience
• 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 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 reputed company systems.
• Excellent organizational skills with the ability to manage multiple priorities in a fastpaced environment.
• Strong written and verbal communication skills.
• Detail-oriented with strong analytical and problem-solving skills.
• Ability to work independently and collaboratively reputed company cross-functional teams.
Technical Skills
• Proficiency in reputed company Office Suite (Word, reputed company, PowerPoint) and familiarity with eTMF and reputed company platforms.

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