Clinical Trial Assistant

About the role

Join us as an Associate Manager, Clinical Trial Assistant (CTA) in the Clinical group at Kelonia Therapeutics. We are seeking a highly motivated individual to support the execution of early-phase clinical trials in a fast-paced, cell and gene therapy environment.

Responsibilities

• Support the planning and execution of clinical trials from study start-up through close-out
• Maintain and track study timelines, milestones, and deliverables (e.g., site activation, enrollment, data cleaning)
• Develop and manage study trackers, dashboards, and status reports to ensure visibility and accountability
• Carefully coordinate study logistics, including vendor activities, clinical supplies, and meeting documentation (as applicable)
• TMF Ownership & Inspection Readiness: Serve as a primary owner of the electronic Trial Master File (eTMF), ensuring documents are complete, accurate, and contemporaneous
• Perform ongoing quality control (QC) reviews of TMF content and ensure compliance with internal SOPs and regulatory requirements
• Maintain continuous inspection readiness and support internal audits and regulatory inspections
• Study Start-Up & Regulatory Support: Support site start-up activities, including collection, review, and tracking of essential documents (e.g., CVs, licenses, 1572s, ICFs)
• Aid in preparation and submission of regulatory and ethics documents (e.g., IRB/EC submissions and amendments)
• Track site activation progress and ensure timely resolution of outstanding items
• Site & Vendor Coordination: Track vendor deliverables, timelines, and documentation; escalate risks as appropriate
• Support coordination of investigator meetings, site communications, and study-related training logistics
• Partner cross-functionally with Clinical Development Operations, Regulatory, Quality, Data Management, and Bioanalytical teams
• Coordinate study team meetings, agendas, and follow-ups to ensure alignment and progress
• Proactively identify operational risks and propose solutions to maintain study timelines
• Compliance & Quality: Ensure adherence to ICH-GCP, company SOPs, and applicable regulatory requirements
• Support safety reporting documentation and tracking, as needed
• Contribute to continuous improvement of clinical operations processes and systems

Requirements

• Bachelor’s degree in life sciences or related field
• 3-6+ years of experience in clinical research or clinical operations (biotech, pharma, or CRO)
• Experience supporting early-phase clinical trials; exposure to cell and gene therapy is a plus
• Experience with clinical systems (e.g., eTMF, EDC, etc.)
• Strong document management and TMF quality control experience
• Proficiency in Microsoft Office (Excel, PowerPoint, Word)
• Exceptional organizational skills and attention to detail
• Strong sense of ownership and accountability in a fast-paced, evolving environment
• Effective communication and collaboration across internal and external stakeholders
• Proactive problem-solving mindset with a focus on execution and quality

Qualifications

• Not specified

Skills

• Not specified

Benefits

• Flexible Time Off
• Flexible Scheduling
• Competitive Benefits Package (health, commuter, and more)
• On-site Perks (free parking, state-of-the-art gym, food hall)

Pay

$109,000 - $144,000 per year

Schedule

Not specified